A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Condition:	Insomnia
Interventions:	Drug: Eszopiclone Drug: Placebo

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
823 participants were screened. Two participants in each arm completed all assessments for the double blind period but discontinued before starting the follow up period (withdrew consent; did not take any single blind medication in follow up period).

	Placebo	Eszopiclone
STARTED	194	194
COMPLETED	148	147
NOT COMPLETED	46	47
Adverse Event	9	14
Protocol Violation	1	1
Withdrawal by Subject	9	13
Lack of Efficacy	20	11
Didnt Meet Entry/Randomization Criteria	4	5
Others	3	3

	Placebo	Eszopiclone
STARTED	146^[1]	145^[2]
COMPLETED	143	144
NOT COMPLETED	3	1
Withdrawal by Subject	3	1

[1]	Two subjects withdrew consent prior to starting the follow up period.
[2]	Two subjects withdrew consent prior to starting the follow up period.

	Placebo	Eszopiclone	Total
Number of Participants [units: participants]	194	194	388
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	194	194	388
Age [units: years] Mean ± Standard Deviation	72.4 ± 5.2	71.6 ± 5.0	72.0 ± 5.1
Gender [units: participants]
Female	119	124	243
Male	75	70	145
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	1	1
Asian	2	4	6
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	9	8	17
White	181	178	359
More than one race	0	0	0
Unknown or Not Reported	2	2	4
Region of Enrollment [units: participants]
United States	194	194	388
Body Mass Index (BMI)^[1] [units: Kilograms/Meters squared] Mean ± Standard Deviation	27.28 ± 4.98	28.25 ± 4.90	27.76 ± 4.96
Height [units: Centimeters] Mean ± Standard Deviation	165.90 ± 9.83	164.70 ± 10.04	165.30 ± 9.94
Weight^[2] [units: kilogram] Mean ± Standard Deviation	75.44 ± 17.07	76.98 ± 16.72	76.21 ± 16.89

[1]	Body mass index (BMI) is measure of body fat based on height and weight that applies to both adult men and women
[2]	Participant Weight in Kilograms

Outcome Measures

1. Primary:

Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. [ Baseline (week 0), Day 1 (post first dose)-12 weeks ]

Measure Type	Primary
Measure Title	Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.
Measure Description	The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose)-12 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	191	191
Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. [units: minutes] Mean ± Standard Deviation	33.18 ± 50.02	63.24 ± 52.76

Statistical Analysis 1 for Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

2. Secondary:

Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. [ Weeks 0, 3, 6, 9, 12, 14, 16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
Measure Description	The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.
Time Frame	Weeks 0, 3, 6, 9, 12, 14, 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. [units: minutes] Mean ± Standard Deviation
Week 3 (n=191,190)	20.65 ± 42.34	51.02 ± 46.43
Week 6 (n=191,191)	32.47 ± 53.31	61.91 ± 54.15
Week 9 (n=191,191)	38.73 ± 57.73	69.00 ± 61.58
Week 12 (n=191,191)	40.86 ± 60.74	70.97 ± 62.18
Week 14 (n=191,191)	42.78 ± 66.52	50.12 ± 68.25
Week 16 (n=191,191)	37.43 ± 67.68	47.17 ± 63.68

No statistical analysis provided for Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.

3. Secondary:

Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. [ Weeks 0, 3, 6, 9, 12, 14, 16 ]

Measure Type	Secondary
Measure Title	Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
Measure Description	The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0, 3, 6, 9, 12, 14, 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. [units: minutes] Mean ± Standard Deviation
Week 0 (n=192,191)	294.03 ± 63.30	297.86 ± 56.14
Week 3 (n=192,192)	314.53 ± 63.52	347.37 ± 57.17
Week 6 (n=192,193)	326.25 ± 65.41	358.72 ± 61.47
Week 9 (n=192,193)	332.47 ± 65.25	365.80 ± 64.97
Week 12 (n=192,193)	334.69 ± 69.91	367.75 ± 66.08
Weeks 3,6,9,12 (double blind average)(n=192,193)	326.98 ± 62.88	360.08 ± 59.40
Week 14 (n=192,193)	336.55 ± 71.13	347.12 ± 72.97
Week 16 (n=192,193)	331.29 ± 72.53	344.20 ± 74.91

No statistical analysis provided for Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.

4. Secondary:

Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period. [ Baseline (week 0), Day 1 (post first dose) - Week12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.
Measure Description	Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - Week12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	191	191
Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period. [units: minutes] Mean ± Standard Deviation	-19.92 ± 46.99	-24.62 ± 46.32

Statistical Analysis 1 for Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0014

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

5. Secondary:

Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Measure Description	Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 3 (n=191,190)	-13.34 ± 41.97	-21.89 ± 44.38
Week 6 (n=191,191)	-19.69 ± 52.08	-24.13 ± 49.20
Week 9 (n=191,191)	-23.02 ± 50.75	-24.21 ± 52.62
Week 12 (n=191,191)	-23.54 ± 54.14	-28.35 ± 49.72
Week 14 (n=191,191)	-25.08 ± 58.99	-17.00 ± 55.55
Week 16 (n=191,191)	-24.61 ± 55.22	-18.73 ± 51.67

No statistical analysis provided for Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points

6. Secondary:

Mean Subject-reported Sleep Latency Reported at Various Study Time Points. [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Measure Description	Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-reported Sleep Latency Reported at Various Study Time Points. [units: minutes] Mean ± Standard Deviation
Week 0 (n=192,191)	82.17 ± 74.08	75.68 ± 56.63
Week 3 (n=192,192)	68.80 ± 64.51	54.69 ± 46.16
Week 6 (n=192,193)	62.57 ± 60.06	52.11 ± 48.66
Week 9 (n=192,193)	59.23 ± 52.05	51.75 ± 51.79
Week 12 (n=192,193)	58.69 ± 51.84	47.66 ± 39.70
Weeks 3,6,9,12 (double blind average)(n=192,193)	62.32 ± 54.82	51.51 ± 43.87
Week 14 (n=192,193)	57.23 ± 49.94	58.89 ± 45.89
Week 16 (n=192,193)	57.62 ± 51.99	57.17 ± 45.40

No statistical analysis provided for Mean Subject-reported Sleep Latency Reported at Various Study Time Points.

7. Secondary:

Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period. [ Baseline (week 0), Day 1 (post first dose) -week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.
Measure Description	Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) -week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	189	191
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period. [units: minutes] Mean ± Standard Deviation	-14.75 ± 38.45	-36.40 ± 41.29

Statistical Analysis 1 for Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

8. Secondary:

Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. [ Baseline (week 0), weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
Measure Description	Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. [units: minutes] Mean ± Standard Deviation
Week 3 (n=188,190)	-8.55 ± 35.80	-29.26 ± 37.68
Week 6 (n=189,191)	-13.46 ± 39.01	-36.57 ± 43.11
Week 9 (n=189,191)	-17.67 ± 44.13	-40.32 ± 45.12
Week 12 (n=189,191)	-19.13 ± 43.39	-39.61 ± 46.48
Week 14 (n=189,191)	-22.72 ± 45.00	-32.27 ± 47.55
Week 16 (n=189,191)	-20.18 ± 48.06	-31.13 ± 51.35

No statistical analysis provided for Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.

9. Secondary:

Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Measure Description	Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 0 (n=190,191)	90.86 ± 51.77	92.66 ± 58.11
Week 3 (n=190,192)	83.17 ± 49.63	64.33 ± 45.97
Week 6 (n=192,193)	77.86 ± 48.82	56.49 ± 44.25
Week 9 (n=192,193)	73.33 ± 49.71	52.75 ± 42.51
Week 12 (n=192,193)	72.02 ± 50.44	53.45 ± 44.23
Weeks 3,6,9,12 (double blind average)(n=192,193)	76.59 ± 47.52	56.68 ± 42.40
Week 14 (n=192,193)	68.39 ± 51.87	60.71 ± 47.07
Week 16 (n=192,193)	71.27 ± 54.61	61.84 ± 48.93

No statistical analysis provided for Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points

10. Secondary:

Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period. [ Baseline (week 0), Day 1 (post first dose) - Week12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.
Measure Description	The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - Week12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	189	191
Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period. [units: number of awakenings] Mean ± Standard Deviation	-0.27 ± 0.72	-0.56 ± 0.79

Statistical Analysis 1 for Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0005

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in study.

11. Secondary:

Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
Measure Description	The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. [units: number of awakenings] Mean ± Standard Deviation
Week 3 (n=188,190)	-0.16 ± .63	-0.46 ± 0.70
Week 6 (n=189,191)	-0.24 ± 0.77	-0.56 ± 0.83
Week 9 (n=189,191)	-0.33 ± 0.81	-0.57 ± 0.88
Week 12 (n=189,191)	-0.35 ± 0.83	-0.65 ± 0.90
Week 14 (n=189,191)	-0.38 ± 0.85	-0.46 ± 0.96
Week 16 (n=189,191)	-0.35 ± 0.87	-0.44 ± 0.97

No statistical analysis provided for Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.

12. Secondary:

Mean Number of Awakenings (Subject-reported) at Various Study Time Points [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Measure Description	Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Number of Awakenings (Subject-reported) at Various Study Time Points [units: number of awakenings] Mean ± Standard Deviation
Week 0 (n=190,191)	1.95 ± 1.00	2.10 ± 1.10
Week 3 (n=190,192)	1.78 ± 0.91	1.66 ± 0.96
Week 6 (n=192,193)	1.72 ± 0.93	1.55 ± 1.00
Week 9 (n=192,193)	1.62 ± 0.94	1.54 ± 1.01
Week 12 (n=192,193)	1.61 ± 0.94	1.46 ± 1.03
Weeks 3,6,9,12 (double blind average)(n=192,193)	1.68 ± 0.90	1.55 ± 0.97
Week 14 (n=192,193)	1.58 ± 0.99	1.65 ± 1.15
Week 16 (n=192,193)	1.61 ± 0.97	1.66 ± 1.11

No statistical analysis provided for Mean Number of Awakenings (Subject-reported) at Various Study Time Points

13. Secondary:

Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - Week12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period
Measure Description	Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - Week12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	189	191
Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period [units: units on a scale] Mean ± Standard Deviation	0.68 ± 1.35	1.39 ± 1.43

Statistical Analysis 1 for Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

14. Secondary:

Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
Measure Description	Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. [units: units on a scale] Mean ± Standard Deviation
Week 3 (n=188,190)	0.37 ± 0.98	1.12 ± 1.18
Week 6 (n=189,191)	0.62 ± 1.31	1.35 ± 1.43
Week 9 (n=189,191)	0.81 ± 1.58	1.52 ± 1.62
Week 12 (n=189,191)	0.92 ± 1.77	1.57 ± 1.73
Week 14 (n=189,191)	1.02 ± 1.88	1.26 ± 2.07
Week 16 (n=189, 191)	0.88 ± 1.96	1.22 ± 2.06

No statistical analysis provided for Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.

15. Secondary:

Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points [ weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Measure Description	Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=190,191)	4.84 ± 1.83	4.68 ± 1.94
Week 3 (n=190,190)	5.22 ± 1.62	5.77 ± 1.82
Week 6 (n=192,193)	5.48 ± 1.56	6.01 ± 1.77
Week 9 (n=192,193)	5.67 ± 1.57	6.17 ± 1.71
Week 12 (n=192,193)	5.78 ± 1.58	6.22 ± 1.70
Weeks 3,6,9,12 (double blind average)(n=192, 193)	5.54 ± 1.50	6.04 ± 1.68
Week 14 (n=192,193)	5.88 ± 1.60	5.91 ± 1.76
Week 16 (n=192,193)	5.73 ± 1.65	5.88 ± 1.75

No statistical analysis provided for Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points

16. Secondary:

Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period. [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.
Measure Description	Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	188	190
Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period. [units: units on a scale] Mean ± Standard Deviation	0.69 ± 1.33	1.33 ± 1.43

Statistical Analysis 1 for Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

17. Secondary:

Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
Measure Description	Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 3 (n=188, 190)	0.40 ± 0.97	1.07 ± 1.16
Week 6 (n=189, 191)	0.62 ± 1.29	1.30 ± 1.44
Week 9 (n=189, 191)	0.82 ± 1.54	1.46 ± 1.63
Week 12 (n=189, 191)	0.93 ± 1.74	1.49 ± 1.73
Week 14 (n=189,191)	1.00 ± 1.88	1.23 ± 2.08
Week 16 (n=189,191)	0.88 ± 1.96	1.15 ± 2.05

No statistical analysis provided for Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points

18. Secondary:

Mean Subject-reported Depth of Sleep at Various Study Time Points [ weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-reported Depth of Sleep at Various Study Time Points
Measure Description	Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-reported Depth of Sleep at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=190,191)	4.87 ± 1.88	4.72 ± 1.90
Week 3 (n=190,192)	5.29 ± 1.62	5.76 ± 1.78
Week 6 (n=192,193)	5.51 ± 1.58	6.00 ± 1.75
Week 9 (n=192,193)	5.71 ± 1.58	6.15 ± 1.73
Week 12 (n=192, 193)	5.82 ± 1.59	6.18 ± 1.70
Weeks 3,6,9,12 (double blind average)(n=192,193)	5.58 ± 1.52	6.02 ± 1.68
Week 14 (n=192,193)	5.89 ± 1.63	5.92 ± 1.78
Week 16 (n=192,193)	5.76 ± 1.69	5.84 ± 1.76

No statistical analysis provided for Mean Subject-reported Depth of Sleep at Various Study Time Points

19. Secondary:

Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period
Measure Description	Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	189	192
Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period [units: units on a scale] Mean ± Standard Deviation	0.61 ± 1.30	1.02 ± 1.31

Statistical Analysis 1 for Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

20. Secondary:

Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
Measure Description	Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 3 (n=189,191)	0.39 ± 0.90	0.76 ± 1.03
Week 6 (n=189,192)	0.55 ± 1.28	0.99 ± 1.29
Week 9 (n=189,192)	0.72 ± 1.53	1.10 ± 1.54
Week 12 (n=189,192)	0.78 ± 1.72	1.21 ± 1.64
Week 14 (n=189,192)	0.85 ± 1.81	1.05 ± 1.92
Week 16 (n=189,192)	0.78 ± 1.89	0.97 ± 2.00

No statistical analysis provided for Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points

21. Secondary:

Mean Subject-reported Daytime Alertness at Various Study Time Points. [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-reported Daytime Alertness at Various Study Time Points.
Measure Description	Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-reported Daytime Alertness at Various Study Time Points. [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=192,193)	5.34 ± 1.97	5.42 ± 2.11
Week 3 (n=190,191)	5.74 ± 1.72	6.18 ± 1.78
Week 6 (n=190,192)	5.89 ± 1.57	6.41 ± 1.68
Week 9 (n=190,192)	6.06 ± 1.51	6.52 ± 1.59
Week 12 (n=190,192)	6.13 ± 1.51	6.64 ± 1.58
Weeks 3,6,9,12 (double blind average)(n=190,192)	5.95 ± 1.50	6.44 ± 1.59
Week 14 (n=190,192)	6.19 ± 1.52	6.47 ± 1.63
Week 16 (n=190,192)	6.13 ± 1.59	6.39 ± 1.60

No statistical analysis provided for Mean Subject-reported Daytime Alertness at Various Study Time Points.

22. Secondary:

Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period
Measure Description	Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	189	192
Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period [units: units on a scale] Mean ± Standard Deviation	0.53 ± 1.29	0.91 ± 1.28

Statistical Analysis 1 for Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

23. Secondary:

Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
Measure Description	Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 3 (n=189,191)	0.36 ± 0.88	0.69 ± 0.98
Week 6 (n=189,192)	0.46 ± 1.25	0.87 ± 1.27
Week 9 (n=189,192)	0.62 ± 1.54	0.98 ± 1.50
Week 12 (n=189,192)	0.69 ± 1.68	1.08 ± 1.60
Week 14 (n=189,192)	0.75 ± 1.81	0.96 ± 1.87
Week 16 (n=189,192)	0.69 ± 1.87	0.87 ± 1.96

No statistical analysis provided for Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points

24. Secondary:

Mean Subject-reported Ability to Function at Various Study Time Points [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-reported Ability to Function at Various Study Time Points
Measure Description	Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-reported Ability to Function at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=192,193)	5.62 ± 2.07	5.69 ± 2.14
Week 3 (n=190,191)	5.98 ± 1.79	6.38 ± 1.79
Week 6 (n=190,192)	6.09 ± 1.61	6.57 ± 1.68
Week 9 (n=190,192)	6.24 ± 1.56	6.69 ± 1.57
Week 12 (n=190,192)	6.32 ± 1.54	6.79 ± 1.55
Weeks 3,6,9,12 (double blind average)(n=190,192)	6.16 ± 1.55	6.61 ± 1.59
Week 14 (n=190,192)	6.38 ± 1.54	6.66 ± 1.57
Week 16 (n=190,192)	6.31 ± 1.62	6.57 ± 1.57

No statistical analysis provided for Mean Subject-reported Ability to Function at Various Study Time Points

25. Secondary:

Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period. [ Baseliine (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.
Measure Description	Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseliine (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	189	192
Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period. [units: units on a scale] Mean ± Standard Deviation	0.50 ± 1.30	0.96 ± 1.25

Statistical Analysis 1 for Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

26. Secondary:

Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
Measure Description	Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. [units: units on a scale] Mean ± Standard Deviation
Week 3 (n=189,191)	0.32 ± 0.89	0.73 ± 0.96
Week 6 (n=189,192)	0.43 ± 1.29	0.93 ± 1.24
Week 9 (n=189,192)	0.60 ± 1.53	1.03 ± 1.48
Week 12 (n=189,192)	0.66 ± 1.71	1.14 ± 1.57
Week 14 (n=189,192)	0.72 ± 1.81	1.00 ± 1.87
Week 16 (n=189,192)	0.66 ± 1.89	0.93 ± 1.93

No statistical analysis provided for Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.

27. Secondary:

Mean Subject-reported Ability to Concentrate at Various Study Time Points [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-reported Ability to Concentrate at Various Study Time Points
Measure Description	Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-reported Ability to Concentrate at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=192,193)	5.66 ± 2.08	5.63 ± 2.15
Week 3 (n=190,191)	5.99 ± 1.78	6.37 ± 1.80
Week 6 (n=190,192)	6.10 ± 1.62	6.57 ± 1.69
Week 9 (n=190,192)	6.27 ± 1.54	6.67 ± 1.58
Week 12 (n=190,192)	6.33 ± 1.52	6.77 ± 1.57
Weeks 3,6,9,12 (double blind average)(n=190,192)	6.17 ± 1.54	6.60 ± 1.60
Week 14 (n=190,192)	6.39 ± 1.53	6.64 ± 1.58
Week 16 (n=190,192)	6.33 ± 1.61	6.56 ± 1.59

No statistical analysis provided for Mean Subject-reported Ability to Concentrate at Various Study Time Points

28. Secondary:

Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period
Measure Description	Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	189	192
Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period [units: units on a scale] Mean ± Standard Deviation	0.52 ± 1.28	0.87 ± 1.29

Statistical Analysis 1 for Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

29. Secondary:

Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
Measure Description	Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. [units: units on a scale] Mean ± Standard Deviation
Week 3 (n=189,191)	0.35 ± 0.88	0.68 ± 0.99
Week 6 (n=189,192)	0.46 ± 1.26	0.84 ± 1.27
Week 9 (n=189,192)	0.61 ± 1.52	0.93 ± 1.51
Week 12 (n=189,192)	0.65 ± 1.71	1.02 ± 1.62
Week 14 (n=189,192)	0.72 ± 1.82	0.89 ± 1.92
Week 16 (n=189,192)	0.64 ± 1.90	0.80 ± 1.97

No statistical analysis provided for Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.

30. Secondary:

Mean Subject-reported Physical Well-Being at Various Study Time Points [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-reported Physical Well-Being at Various Study Time Points
Measure Description	Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-reported Physical Well-Being at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=192,193)	5.45 ± 1.98	5.62 ± 2.14
Week 3 (n=190,191)	5.80 ± 1.74	6.30 ± 1.77
Week 6 (n=190,192)	5.92 ± 1.57	6.46 ± 1.65
Week 9 (n=190,192)	6.06 ± 1.53	6.56 ± 1.56
Week 12 (n=190,192)	6.11 ± 1.52	6.65 ± 1.53
Weeks 3,6,9,12 (double blind average)(n=190,192)	5.97 ± 1.51	6.49 ± 1.56
Week 14 (n=190,192)	6.18 ± 1.53	6.51 ± 1.56
Week 16 (n=190,192)	6.09 ± 1.61	6.43 ± 1.56

No statistical analysis provided for Mean Subject-reported Physical Well-Being at Various Study Time Points

31. Secondary:

Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose)- week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period
Measure Description	Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose)- week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	110	93
Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period [units: number of naps] Mean ± Standard Deviation	-0.78 ± 2.30	-1.23 ± 2.11

Statistical Analysis 1 for Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1175

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

32. Secondary:

Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
Measure Description	Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points [units: number of naps] Mean ± Standard Deviation
Week 3 (n=110,92)	-0.39 ± 2.04	-1.15 ± 2.02
Week 6 (n=110,93)	-0.80 ± 2.49	-1.26 ± 2.21
Week 9 (n=110, 93)	-0.96 ± 2.67	-1.33 ± 2.51
Week 12 (n=110, 93)	-0.96 ± 2.88	-1.18 ± 2.58
Week 14 (n=110,93)	-0.71 ± 2.93	-1.00 ± 2.31
Week 16 (n=110,93)	-0.92 ± 2.79	-1.29 ± 2.49

No statistical analysis provided for Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points

33. Secondary:

Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
Measure Description	The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. [units: number of naps] Mean ± Standard Deviation
Week 0 (n=111,94)	4.03 ± 4.41	3.88 ± 3.55
Week 3 (n=110,92)	3.67 ± 4.67	2.76 ± 2.96
Week 6 (n=110,93)	3.26 ± 4.25	2.64 ± 3.00
Week 9 (n=110,93)	3.10 ± 4.57	2.57 ± 2.63
Week 12 (n=110,93)	3.10 ± 5.05	2.71 ± 3.06
Weeks 3,6,9,12 (double blind average)(n=110,93)	3.28 ± 4.51	2.66 ± 2.74
Week 14 (n=110,93)	3.35 ± 5.32	2.90 ± 3.12
Week 16 (n=110,93)	3.14 ± 4.63	2.61 ± 3.15

No statistical analysis provided for Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.

34. Secondary:

Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period
Measure Description	Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	110	93
Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period [units: minutes] Mean ± Standard Deviation	-36.02 ± 125.59	-60.06 ± 156.49

Statistical Analysis 1 for Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0717

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

35. Secondary:

Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
Measure Description	Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. [units: minutes] Mean ± Standard Deviation
Week 3 (n=110,92)	-21.66 ± 116.53	-59.06 ± 158.00
Week 6 (n=110,93)	-40.02 ± 140.47	-65.99 ± 163.12
Week 9 (n=110,93)	-40.25 ± 146.42	-56.59 ± 184.47
Week 12 (n=110,93)	-42.15 ± 136.85	-58.22 ± 163.87
Week 14 (n=110,93)	-27.28 ± 142.36	-44.48 ± 165.67
Week 16 (n=110,93)	-38.14 ± 137.69	-49.15 ± 202.13

No statistical analysis provided for Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.

36. Secondary:

Mean Subject-Reported Total Nap Time at Various Study Time Points [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-Reported Total Nap Time at Various Study Time Points
Measure Description	The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-Reported Total Nap Time at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 0 (n=111,94)	189.31 ± 262.08	171.62 ± 237.75
Week 3 (n=110,92)	169.24 ± 253.66	114.43 ± 151.26
Week 6 (n=110,93)	150.88 ± 226.90	106.99 ± 133.85
Week 9 (n=110,93)	150.65 ± 234.11	116.39 ± 156.42
Week 12 (n=110,93)	148.75 ± 256.87	114.76 ± 149.73
Weeks 3,6,9,12 (double blind average)(n=110,93)	154.88 ± 237.82	112.92 ± 135.34
Week 14 (n=110,93)	163.61 ± 274.13	128.50 ± 173.51
Week 16 (n=110,93)	152.76 ± 246.50	123.83 ± 173.58

No statistical analysis provided for Mean Subject-Reported Total Nap Time at Various Study Time Points

37. Secondary:

Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period
Measure Description	Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	110	93
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period [units: percentage of total asleep time] Mean ± Standard Deviation	-2.44 ± 8.29	-2.98 ± 5.53

Statistical Analysis 1 for Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.1182

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

38. Secondary:

Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Measure Description	Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points [units: percentage of total asleep time] Mean ± Standard Deviation
Week 3 (n=110,92)	-1.78 ± 7.00	-2.77 ± 5.57
Week 6 (n=110,93)	-2.52 ± 9.09	-3.16 ± 5.80
Week 9 (n=110,93)	-2.72 ± 9.26	-2.94 ± 6.24
Week 12 (n=110,93)	-2.76 ± 8.98	-3.04 ± 5.82
Week 14 (n=110,93)	-2.31 ± 9.22	-2.14 ± 5.82
Week 16 (n=110,93)	-2.55 ± 8.62	-2.38 ± 6.72

No statistical analysis provided for Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points

39. Secondary:

Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Measure Description	Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points [units: percentage of total asleep time] Median ± Standard Deviation
Week 0 (n=111,94)	9.05 ± 13.89	7.02 ± 8.34
Week 3 (n=110,92)	7.35 ± 11.94	4.33 ± 5.53
Week 6 (n=110,93)	6.61 ± 11.73	3.91 ± 4.83
Week 9 (n=110,93)	6.41 ± 11.04	4.13 ± 5.15
Week 12 (n=110,93)	6.37 ± 11.77	4.04 ± 5.00
Weeks 3,6,9,12 (double blind average)(n=110,93)	6.68 ± 11.37	4.09 ± 4.75
Week 14 (n=110,93)	6.82 ± 11.17	4.93 ± 6.19
Week 16 (n=110,93)	6.57 ± 11.00	4.69 ± 6.27

No statistical analysis provided for Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points

40. Secondary:

Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
Measure Description	Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	62	61
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [units: minutes] Mean ± Standard Deviation	14.40 ± 38.14	17.96 ± 34.71

Statistical Analysis 1 for Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.3010

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

41. Secondary:

Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
Measure Description	Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.
Time Frame	Baseline (week 0), Weeks 1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 1 (n=60,58)	3.72 ± 54.09	14.97 ± 36.91
Week 4 (n=61,61)	17.21 ± 39.97	16.89 ± 41.00
Week 7 (n=62,61)	15.72 ± 57.85	22.12 ± 41.02
Week 12 (n=62,61)	18.93 ± 44.73	18.08 ± 52.57
Week 13 (n=62,61)	15.36 ± 51.72	-0.60 ± 56.17
Week 15 (n=62,61)	13.82 ± 43.48	4.06 ± 47.60

No statistical analysis provided for Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points

42. Secondary:

Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points [ Weeks 0,1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Measure Description	Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values).
Time Frame	Weeks 0,1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 0 (n=64,61)	351.06 ± 86.05	367.95 ± 60.86
Week 1 (n=64,64)	354.11 ± 94.76	381.52 ± 73.83
Week 4 (n=67,67)	366.69 ± 78.34	382.39 ± 69.41
Week 7 (n=68,67)	368.58 ± 86.48	386.96 ± 63.89
Week 12 (n=68,67)	368.70 ± 83.39	382.04 ± 69.98
Weeks 1,4,7,12 (double blind average)(n=68,67)	365.13 ± 79.31	383.30 ± 63.78
Week 13 (n=68,67)	366.47 ± 81.33	364.87 ± 74.16
Week 15 (n=68,67)	365.73 ± 74.47	369.23 ± 64.82

No statistical analysis provided for Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points

43. Secondary:

Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
Measure Description	Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	62	61
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [units: minutes] Mean ± Standard Deviation	0.00 ± 40.75	1.47 ± 26.76

Statistical Analysis 1 for Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.7800

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

44. Secondary:

Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
Measure Description	Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time Frame	Baseline (week 0), Weeks 1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 1 (n=60,58)	9.06 ± 74.76	-0.25 ± 18.92
Week 4 (n=61,61)	-2.16 ± 44.61	-1.48 ± 27.74
Week 7 (n=62,61)	0.12 ± 52.95	-1.62 ± 26.28
Week 12 (n=62,61)	-3.92 ± 36.22	9.34 ± 57.32
Week 13 (n=62,61)	-0.69 ± 59.32	16.13 ± 66.04
Week 15 (n=62,61)	-3.66 ± 39.21	6.44 ± 36.59

No statistical analysis provided for Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points

45. Secondary:

Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. [ Weeks 0,1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Measure Description	Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.
Time Frame	Weeks 0,1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) & average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. [units: minutes] Mean ± Standard Deviation
Week 0 (n=64,61)	31.34 ± 65.06	23.89 ± 24.50
Week 1 (n=64,64)	37.74 ± 78.14	26.72 ± 36.56
Week 4 (n=67,67)	28.55 ± 35.46	26.62 ± 43.36
Week 7 (n=68,67)	31.06 ± 42.82	26.89 ± 33.34
Week 12 (n=68,67)	27.89 ± 38.78	36.93 ± 57.69
Weeks 1,4,7,12 (double blind average)(n=68,67)	31.20 ± 36.89	29.22 ± 35.92
Week 13 (n=68,67)	30.40 ± 41.05	43.06 ± 64.37
Week 15 (n=68,67)	28.80 ± 37.75	34.35 ± 40.34

No statistical analysis provided for Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.

46. Secondary:

Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
Measure Description	Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	62	61
Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [units: minutes] Mean ± Standard Deviation	4.50 ± 19.54	-4.24 ± 22.91

Statistical Analysis 1 for Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0803

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

47. Secondary:

Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Measure Description	Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time Frame	Baseline (week 0), Weeks 1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 1 (n=59,58)	3.17 ± 16.23	-6.59 ± 23.78
Week 4 (n=61,61)	4.67 ± 23.36	-3.88 ± 26.95
Week 7 (n=62,61)	6.57 ± 30.27	-4.19 ± 25.25
Week 12 (n=62,61)	3.24 ± 17.90	-2.54 ± 24.42
Week 13 (n=62,61)	4.98 ± 22.35	0.68 ± 23.79
Week 15 (n=62,61)	7.74 ± 25.70	-0.27 ± 24.10

No statistical analysis provided for Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points

48. Secondary:

Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points [ weeks 0,1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Measure Description	Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).
Time Frame	weeks 0,1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 0 (n=64,61)	60.27 ± 29.51	63.75 ± 29.11
Week 1 (n=63,64)	63.53 ± 31.09	55.39 ± 22.11
Week 4 (n=67,67)	64.16 ± 32.11	58.86 ± 24.51
Week 7 (n=68,67)	65.81 ± 35.11	58.09 ± 22.41
Week 12 (n=68,67)	62.41 ± 30.09	60.22 ± 23.10
Weeks 1,4,7,12 (double blind average)(n=68,67)	63.69 ± 29.90	58.21 ± 20.76
Week 13 (n=68,67)	64.09 ± 31.39	63.01 ± 27.84
Week 15 (n=68,67)	67.07 ± 37.40	62.27 ± 25.77

No statistical analysis provided for Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points

49. Secondary:

Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
Measure Description	Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	62	61
Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [units: number of awakenings] Mean ± Standard Deviation	0.87 ± 3.65	-0.18 ± 4.28

Statistical Analysis 1 for Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.2643

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

50. Secondary:

Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
Measure Description	Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time Frame	Baseline (week 0), Weeks 1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. [units: number of awakenings] Mean ± Standard Deviation
Week 1 (n=59,58)	0.76 ± 3.09	-0.54 ± 4.19
Week 4 (n=61,61)	0.79 ± 4.62	0.04 ± 5.22
Week 7 (n=62,61)	0.88 ± 4.73	-0.21 ± 5.05
Week 12 (n=62,61)	0.95 ± 4.60	-0.10 ± 4.93
Week 13 (n=62,61)	1.10 ± 4.69	0.01 ± 4.93
Week 15 (n=62,61)	1.36 ± 4.35	-0.13 ± 5.02

No statistical analysis provided for Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.

51. Secondary:

Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points [ Weeks 0,1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Measure Description	Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Time Frame	Weeks 0,1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points [units: number of awakenings] Mean ± Standard Deviation
Week 0 (n=64,61)	21.49 ± 7.53	22.84 ± 6.94
Week 1 (n=63,64)	22.42 ± 7.17	21.86 ± 5.96
Week 4 (n=67,67)	22.28 ± 7.30	22.51 ± 6.16
Week 7 (n=68,67)	22.52 ± 7.93	22.19 ± 6.08
Week 12 (n=68,67)	22.36 ± 7.76	22.37 ± 6.25
Weeks 1,4,7,12 (double blind average)(n=68,67)	22.40 ± 7.15	22.27 ± 5.66
Week 13 (n=68,67)	22.55 ± 7.57	22.48 ± 7.30
Week 15 (n=68,67)	22.87 ± 7.71	22.38 ± 5.99

No statistical analysis provided for Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points

52. Secondary:

Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
Measure Description	Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	58	58
Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period [units: number of naps] Mean ± Standard Deviation	1.61 ± 9.06	-2.67 ± 12.61

Statistical Analysis 1 for Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0765

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

53. Secondary:

Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Measure Description	Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time Frame	Baseline (week 0), Weeks 1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points [units: number of naps] Mean ± Standard Deviation
Week 1 (n=57,55)	1.33 ± 9.15	-0.62 ± 12.92
Week 4 (n=57,58)	1.02 ± 11.73	-3.43 ± 13.36
Week 7 (n=58,58)	1.68 ± 10.63	-2.83 ± 16.76
Week 12 (n=58,58)	1.86 ± 9.83	-3.47 ± 15.15
Week 13 (n=58,58)	2.73 ± 10.54	-4.58 ± 13.69
Week 15 (n=58,58)	3.41 ± 11.22	-0.64 ± 12.16

No statistical analysis provided for Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points

54. Secondary:

Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points [ Week 0,1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Measure Description	The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Time Frame	Week 0,1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points [units: number of naps] Mean ± Standard Deviation
Week 0 (n=62,58)	20.52 ± 15.63	22.33 ± 15.42
Week 1 (n=57,55)	20.94 ± 14.99	21.69 ± 15.38
Week 4 (n=57,58)	20.63 ± 15.38	18.90 ± 13.85
Week 7 (n=58,58)	21.07 ± 14.93	19.50 ± 15.18
Week 12 (n=58,58)	21.25 ± 14.29	18.86 ± 15.18
Weeks 1,4,7,12 (double blind average)(n=58,58)	21.01 ± 13.90	19.66 ± 12.91
Week 13 (n=58,58)	22.12 ± 15.97	17.75 ± 12.66
Week 15 (n=58,58)	22.80 ± 15.03	21.69 ± 14.45

No statistical analysis provided for Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points

55. Secondary:

Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
Measure Description	Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	58	58
Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period [units: minutes] Mean ± Standard Deviation	21.26 ± 196.66	-40.91 ± 307.98

Statistical Analysis 1 for Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.2967

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

56. Secondary:

Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
Measure Description	Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time Frame	Baseline (week 0), Weeks 1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points [units: minutes] Mean ± Standard Deviation
Week 1 (n=57,55)	2.37 ± 184.85	6.56 ± 285.45
Week 4 (n=57,58)	6.37 ± 252.54	-56.87 ± 336.01
Week 7 (n=58,58)	23.03 ± 220.20	-31.85 ± 428.85
Week 12 (n=58,58)	38.86 ± 229.45	-73.67 ± 338.69
Week 13 (n=58,58)	64.84 ± 275.99	-87.50 ± 291.01
Week 15 (n=58,58)	61.28 ± 235.24	-1.99 ± 240.85

No statistical analysis provided for Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points

57. Secondary:

Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. [ Week 0,1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
Measure Description	The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Time Frame	Week 0,1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. [units: minutes] Mean ± Standard Deviation
Week 0 (n=62,58)	418.49 ± 368.31	438.02 ± 325.66
Week 1 (n=57,55)	399.19 ± 298.18	445.84 ± 358.33
Week 4 (n=57,58)	403.18 ± 328.59	381.15 ± 335.03
Week 7 (n=58,58)	414.68 ± 315.20	406.16 ± 387.87
Week 12 (n=58,58)	430.50 ± 313.11	364.34 ± 313.03
Weeks 1,4,7,12 (double blind average)(n=58,58)	412.91 ± 292.66	397.11 ± 305.65
Week 13 (n=58,58)	456.48 ± 352.10	350.52 ± 262.61
Week 15 (n=58,58)	452.93 ± 310.68	436.03 ± 297.32

No statistical analysis provided for Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.

58. Secondary:

Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period. [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.
Measure Description	Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	58	58
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period. [units: percentage of total asleep time] Mean ± Standard Deviation	0.45 ± 7.84	-1.75 ± 8.46

Statistical Analysis 1 for Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.0634

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

59. Secondary:

Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points [ Baseline (week 0), Weeks 1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
Measure Description	Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.
Time Frame	Baseline (week 0), Weeks 1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points [units: percentage of total asleep time] Mean ± Standard Deviation
Week 1 (n=57,55)	1.38 ± 13.89	-0.17 ± 7.95
Week 4 (n=57,58)	-0.56 ± 8.64	-2.14 ± 9.54
Week 7 (n=58,58)	0.18 ± 9.21	-1.75 ± 11.22
Week 12 (n=58,58)	0.46 ± 7.76	-2.70 ± 9.24
Week 13 (n=58,58)	0.94 ± 7.96	-2.63 ± 8.98
Week 15 (n=58,58)	0.95 ± 8.11	-0.04 ± 7.41

No statistical analysis provided for Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points

60. Secondary:

Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points [ Week 0,1,4,7,12,13,15 ]

Measure Type	Secondary
Measure Title	Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
Measure Description	The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).
Time Frame	Week 0,1,4,7,12,13,15
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	72	69
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points [units: percentage of total asleep time] Median ± Standard Deviation
Week 0 (n=62,58)	15.12 ± 15.32	14.05 ± 9.41
Week 1 (n=57,55)	16.29 ± 17.55	13.89 ± 10.19
Week 4 (n=57,58)	14.35 ± 13.63	11.92 ± 9.24
Week 7 (n=58,58)	14.90 ± 12.97	12.30 ± 10.35
Week 12 (n=58,58)	15.18 ± 13.23	11.36 ± 9.14
Weeks 1,4,7,12 (double blind average)(n=58,58)	15.16 ± 12.87	12.30 ± 8.64
Week 13 (n=58,58)	15.66 ± 13.84	11.43 ± 8.28
Week 15 (n=58,58)	15.66 ± 12.42	14.01 ± 8.85

No statistical analysis provided for Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points

61. Secondary:

Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period [ Baseline (week 0), Day 1 (post first dose) - week 12 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period
Measure Description	Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time Frame	Baseline (week 0), Day 1 (post first dose) - week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	180	182
Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period [units: units on a scale] Mean ± Standard Deviation	-3.42 ± 4.38	-5.67 ± 5.26

Statistical Analysis 1 for Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Multiple comparisons not applied due to only two treatments in the study.

62. Secondary:

Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points [ Baseline (week 0), Weeks 3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
Measure Description	Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.
Time Frame	Baseline (week 0), Weeks 3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 3 (n=179,181)	-2.74 ± 4.51	-4.94 ± 5.38
Week 6 (n=180,181)	-3.35 ± 4.89	-5.67 ± 5.88
Week 9 (n=180,182)	-3.55 ± 5.10	-5.89 ± 5.88
Week 12 (n=180,182)	-4.05 ± 5.15	-6.18 ± 5.96
Week 14 (n=181,182)	-3.93 ± 5.25	-4.06 ± 5.88
Week 16 (n=181,182)	-2.96 ± 5.16	-2.96 ± 5.24

No statistical analysis provided for Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points

63. Secondary:

Mean Insomnia Severity Index Total Scores at Various Study Time Points [ Weeks 0,3,6,9,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Insomnia Severity Index Total Scores at Various Study Time Points
Measure Description	The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time Frame	Weeks 0,3,6,9,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Insomnia Severity Index Total Scores at Various Study Time Points [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=192,190)	16.34 ± 4.18	16.12 ± 4.81
Week 3 (n=180,183)	13.52 ± 5.11	11.09 ± 5.48
Week 6 (n=181,184)	12.87 ± 5.26	10.40 ± 5.87
Week 9 (n=181,185)	12.66 ± 5.58	10.12 ± 5.77
Week 12 (n=181,185)	12.16 ± 5.51	9.84 ± 5.63
Weeks 3,6,9,12 (double blind average)(n=181,185)	12.80 ± 4.87	10.36 ± 5.16
Week 14 (n=182,185)	12.30 ± 5.68	11.94 ± 5.56
Week 16 (n=182,185)	13.28 ± 5.39	13.05 ± 5.49

No statistical analysis provided for Mean Insomnia Severity Index Total Scores at Various Study Time Points

64. Secondary:

Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale [ Baseline (week 0), Weeks 6, 12, 16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale
Measure Description	Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.
Time Frame	Baseline (week 0), Weeks 6, 12, 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale [units: units on a scale] Mean ± Standard Deviation
Week 6 (n=164,165)	1.01 ± 7.73	1.00 ± 7.28
Week 12 (n=165,166)	1.38 ± 7.60	1.01 ± 7.14
Week 16 (n=166,166)	0.69 ± 7.99	0.39 ± 6.78

No statistical analysis provided for Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale

65. Secondary:

Mean Physical Component Summary of the Short Form-36 Scale Scores. [ Weeks 0,6,12,16 ]

Measure Type	Secondary
Measure Title	Mean Physical Component Summary of the Short Form-36 Scale Scores.
Measure Description	This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).
Time Frame	Weeks 0,6,12,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Physical Component Summary of the Short Form-36 Scale Scores. [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=192,190)	43.99 ± 10.67	45.39 ± 9.78
Week 6 (n=165,168)	45.06 ± 10.98	46.08 ± 10.00
Week 12 (n=166,169)	45.38 ± 10.57	46.12 ± 9.42
Week 16 (n=167,169)	44.70 ± 10.98	45.51 ± 9.80

No statistical analysis provided for Mean Physical Component Summary of the Short Form-36 Scale Scores.

66. Secondary:

Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores [ Baseline (week 0), Weeks 6,12,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores
Measure Description	Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.
Time Frame	Baseline (week 0), Weeks 6,12,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores [units: units on a scale] Mean ± Standard Deviation
Week 6 (n=164,165)	-0.44 ± 7.45	0.96 ± 8.59
Week 12 (n=165,166)	-0.94 ± 8.00	0.83 ± 8.54
Week 16 (n=166,166)	-1.22 ± 8.94	0.20 ± 7.46

No statistical analysis provided for Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores

67. Secondary:

Mean Mental Component Summary of the Short Form-36 Scale Scores [ Weeks 0,6,12,16 ]

Measure Type	Secondary
Measure Title	Mean Mental Component Summary of the Short Form-36 Scale Scores
Measure Description	This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16).
Time Frame	Weeks 0,6,12,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Mental Component Summary of the Short Form-36 Scale Scores [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=192,190)	49.69 ± 9.33	49.29 ± 10.04
Week 6 (n=165,168)	49.49 ± 10.03	49.96 ± 10.03
Week 12 (n=166,169)	48.98 ± 10.19	49.86 ± 9.09
Week 16 (n=167,169)	48.68 ± 10.61	49.23 ± 9.92

No statistical analysis provided for Mean Mental Component Summary of the Short Form-36 Scale Scores

68. Secondary:

Mean Change From Baseline in the Sheehan Disability Scale Total Score. [ Baseline (week 0), Weeks 6,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline in the Sheehan Disability Scale Total Score.
Measure Description	Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.
Time Frame	Baseline (week 0), Weeks 6,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Change From Baseline in the Sheehan Disability Scale Total Score. [units: units on a scale] Mean ± Standard Deviation
Week 6 (n=164,165)	-2.60 ± 7.63	-4.05 ± 7.42
Week 12 (n=165,166)	-3.73 ± 7.59	-4.48 ± 7.72
Week 14 (n=166,166)	-3.11 ± 7.88	-3.52 ± 7.15
Week 16 (n=166,166)	-3.33 ± 8.09	-2.47 ± 7.14

No statistical analysis provided for Mean Change From Baseline in the Sheehan Disability Scale Total Score.

69. Secondary:

Mean Sheehan Disability Total Scores [ Weeks 0,6,12,14,16 ]

Measure Type	Secondary
Measure Title	Mean Sheehan Disability Total Scores
Measure Description	Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16).
Time Frame	Weeks 0,6,12,14,16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Measured Values

	Placebo	Eszopiclone
Number of Participants Analyzed [units: participants]	194	194
Mean Sheehan Disability Total Scores [units: units on a scale] Mean ± Standard Deviation
Week 0 (n=192,190)	11.38 ± 7.80	11.13 ± 7.63
Week 6 (n=165,168)	8.87 ± 6.82	7.52 ± 6.81
Week 12 (n=166,169)	7.70 ± 6.48	7.08 ± 6.85
Week 14 (n=166,166)	8.37 ± 7.21	8.03 ± 7.10
Week 16 (n=167,169)	8.12 ± 7.10	9.06 ± 7.71

No statistical analysis provided for Mean Sheehan Disability Total Scores

Responsible Party:	Sepracor Inc. ( Executive Medical Director, Clinical Research )
Study ID Numbers:	190-904
Study First Received:	October 9, 2006
Results First Received:	February 13, 2009
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00386334 History of Changes
Health Authority:	United States: Food and Drug Administration