Recruitment Details

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

Pre-Assignment Details

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).

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Participant Flow for 2 periods

	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

Reporting Groups

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

Baseline Measures

	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.  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 ]

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 ]

3.  Secondary:

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

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 ]

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 ]

6.  Secondary:

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

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 ]

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 ]

9.  Secondary:

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

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 ]

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 ]

12.  Secondary:

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

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 ]

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 ]

15.  Secondary:

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

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 ]

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 ]

18.  Secondary:

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

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 ]

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 ]

21.  Secondary:

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

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 ]

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 ]

24.  Secondary:

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

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 ]

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 ]

27.  Secondary:

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

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 ]

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 ]

30.  Secondary:

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

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 ]

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 ]

33.  Secondary:

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

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 ]

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 ]

36.  Secondary:

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

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 ]

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 ]

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 ]

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 ]

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 ]

42.  Secondary:

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

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 ]

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 ]

45.  Secondary:

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

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 ]

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 ]

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 ]

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 ]

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 ]

51.  Secondary:

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

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 ]

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 ]

54.  Secondary:

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

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 ]

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 ]

57.  Secondary:

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

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 ]

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 ]

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 ]

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 ]

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 ]

63.  Secondary:

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

64.  Secondary:

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

65.  Secondary:

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

66.  Secondary:

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

67.  Secondary:

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

68.  Secondary:

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

69.  Secondary:

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