ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00593736
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : March 9, 2010
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Sleep Disorders, Circadian Rhythm
Interventions Drug: Ramelteon
Drug: Placebo
Enrollment 132
Recruitment Details Subjects enrolled at 47 sites in the United States from 10 October 2007 to 23 May 2008.
Pre-assignment Details Subjects were screened for 14 days, entered a 7-day placebo run-in, and then were randomized to once-daily (QD) treatment. To enter the double-blind randomization period, subjects must have met the eligible inclusion and none of the exclusion criteria and met sleep diagnostic criteria established during screening polysomnography.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks. Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks. Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks. Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Period Title: Screening Period and Placebo Run-in
Started 0 0 0 549
Completed 0 0 0 132
Not Completed 0 0 0 417
Reason Not Completed
Adverse Event             0             0             0             3
Lost to Follow-up             0             0             0             9
Withdrawal by Subject             0             0             0             43
Study Termination             0             0             0             15
Did Not Meet Criteria             0             0             0             322
Various             0             0             0             25
Period Title: Treatment Period and Placebo Run-out
Started 32 33 35 32
Completed 29 31 30 28
Not Completed 3 2 5 4
Reason Not Completed
Lost to Follow-up             2             1             2             0
Protocol Violation             0             0             1             1
Withdrawal by Subject             0             0             1             3
Various             1             1             1             0
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD Total
Hide Arm/Group Description Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks. Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks. Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks. Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 32 33 35 32 132
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 33 participants 35 participants 32 participants 132 participants
29.6  (9.36) 33.7  (12.31) 29.3  (9.40) 33.1  (13.08) 31.4  (11.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 35 participants 32 participants 132 participants
Female
18
  56.3%
17
  51.5%
17
  48.6%
12
  37.5%
64
  48.5%
Male
14
  43.8%
16
  48.5%
18
  51.4%
20
  62.5%
68
  51.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 35 participants 32 participants 132 participants
Hispanic or Latino
19
  59.4%
19
  57.6%
19
  54.3%
18
  56.3%
75
  56.8%
Not Hispanic or Latino
13
  40.6%
14
  42.4%
16
  45.7%
14
  43.8%
57
  43.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 35 participants 32 participants 132 participants
American Indian or Alaska Native
1
   3.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Asian
2
   6.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.1%
1
   0.8%
Black or African American
4
  12.5%
3
   9.1%
3
   8.6%
3
   9.4%
13
   9.8%
White
24
  75.0%
30
  90.9%
32
  91.4%
28
  87.5%
114
  86.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
Pharmacologic sleep aid needed to sleep   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 32 participants 33 participants 35 participants 32 participants 132 participants
0 31 30 33 32 126
1 0 0 1 0 1
2 0 2 1 0 3
3 1 1 0 0 2
4 0 0 0 0 0
>4 0 0 0 0 0
[1]
Measure Description: For the question, "Do you use of pharmacological assistance to sleep," an answer of 'no'=0 and 'yes' resulted in the question, "If yes, how often per week?" 1=1 day/week; 2=2 days/week; 3=3 days/week; 4=4 days/week; >4=more than 4 days/week.
Time asleep (habitual and desired)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 32 participants 33 participants 35 participants 32 participants 132 participants
Habitual 368.0  (89.27) 406.4  (105.29) 371.6  (95.29) 384.8  (78.88) 382.6  (93.01)
Desired 341.7  (76.46) 347.7  (72.05) 331.3  (75.30) 330.9  (64.43) 337.8  (72.06)
Time to fall asleep (habitual and desired)   [1] 
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 32 participants 33 participants 35 participants 32 participants 132 participants
Habitual 83.0  (78.85) 76.8  (59.89) 90.4  (64.79) 69.8  (58.72) 80.2  (65.66)
Desired 167.5  (53.25) 164.4  (51.43) 165.0  (48.94) 155.0  (55.61) 163.0  (51.89)
[1]
Measure Description: Habitual sleep time defined as the time it takes to fall asleep starting at subject’s usual, later sleep time. Desired sleep time defined as the time it takes to fall asleep at subject’s preferred, earlier sleep time.
1.Primary Outcome
Title Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Hide Description The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the full analysis set (FAS), which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
59.30  (6.684) 39.40  (6.352) 55.94  (6.482) 55.12  (6.871)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the analysis of covariance (ANCOVA) model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.646
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments Least Squares (LS) means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.929
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
2.Secondary Outcome
Title Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Hide Description The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
48.36  (6.849) 38.61  (6.611) 45.29  (6.732) 46.64  (6.983)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.854
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.383
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.883
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
3.Secondary Outcome
Title Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Hide Description The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
376.41  (8.158) 383.51  (7.876) 378.62  (8.033) 366.23  (8.421)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.365
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.121
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
4.Secondary Outcome
Title Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Hide Description The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
389.72  (8.866) 378.04  (8.683) 379.17  (8.843) 388.51  (9.064)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.920
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.382
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.439
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
5.Secondary Outcome
Title Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)
Hide Description The total sleep time divided by time-in-bed, multiplied by 100.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time asleep
64.49  (3.385) 71.83  (3.213) 65.70  (3.272) 64.64  (3.460)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
6.Secondary Outcome
Title Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)
Hide Description The total sleep time divided by time-in-bed, multiplied by 100.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time asleep
69.07  (3.244) 75.13  (3.126) 70.19  (3.181) 70.99  (3.286)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
7.Secondary Outcome
Title Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)
Hide Description The total sleep time divided by time-in-bed, multiplied by 100.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time asleep
78.42  (1.701) 79.90  (1.642) 78.89  (1.675) 76.30  (1.756)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.365
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.121
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.268
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
8.Secondary Outcome
Title Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)
Hide Description The total sleep time divided by time-in-bed, multiplied by 100.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time asleep
81.09  (1.706) 79.33  (1.671) 78.92  (1.702) 80.80  (1.745)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.900
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.525
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.418
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
9.Secondary Outcome
Title Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Hide Description The number of wake minutes after the onset of persistent sleep prior to the end of recording.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
46.26  (5.880) 62.86  (5.704) 51.06  (5.758) 62.11  (6.035)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.926
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
10.Secondary Outcome
Title Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Hide Description The number of wake minutes after the onset of persistent sleep prior to the end of recording.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
43.36  (6.124) 63.47  (6.032) 59.77  (6.103) 48.88  (6.240)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.511
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
11.Secondary Outcome
Title Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Hide Description The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: number of awakenings
9.22  (0.835) 10.79  (0.795) 10.79  (0.815) 9.67  (0.853)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.691
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.323
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.324
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
12.Secondary Outcome
Title Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Hide Description The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: number of awakenings
8.08  (0.806) 9.33  (0.783) 9.87  (0.800) 9.51  (0.822)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.197
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.737
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
13.Secondary Outcome
Title Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Hide Description The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
63.92  (6.096) 50.67  (5.785) 61.67  (5.892) 63.63  (6.230)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.972
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.811
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
14.Secondary Outcome
Title Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Hide Description The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
55.69  (5.841) 44.68  (5.629) 53.64  (5.728) 52.19  (5.918)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.659
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.337
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
15.Secondary Outcome
Title Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Hide Description Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: hours on a 24-hour clock
22.40  (0.016) 22.36  (0.016) 22.35  (0.016) 22.35  (0.033)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.206
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.800
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
16.Secondary Outcome
Title Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Hide Description Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: hours on a 24-hour clock
22.36  (0.016) 22.36  (0.016) 22.36  (0.016) 22.33  (0.016)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
17.Secondary Outcome
Title Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Hide Description Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 33 30
Least Squares Mean (Standard Error)
Unit of Measure: hours on a 24-hour clock
06.35  (0.033) 06.31  (0.033) 06.30  (0.033) 06.26  (0.033)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.521
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
18.Secondary Outcome
Title Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Hide Description Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 30 32 32 30
Least Squares Mean (Standard Error)
Unit of Measure: hours on a 24-hour clock
06.31  (0.066) 06.21  (0.066) 06.40  (0.066) 06.26  (0.083)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.675
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.566
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
19.Secondary Outcome
Title Total Sleep Time Measured by Actigraphy (Nights 6-7)
Hide Description Total sleep time calculated using the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 28 28 29
Least Squares Mean (Standard Error)
Unit of Measure: minutes
374.37  (8.741) 393.37  (8.632) 370.83  (8.352) 369.05  (8.457)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.643
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.875
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
20.Secondary Outcome
Title Total Sleep Time Measured by Actigraphy (Nights 13-14)
Hide Description Total sleep time pertains to the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 27 30 27
Least Squares Mean (Standard Error)
Unit of Measure: minutes
391.61  (8.661) 390.76  (8.982) 370.80  (8.228) 378.91  (8.845)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.286
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.318
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.483
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
21.Secondary Outcome
Title Sleep Efficiency Measured by Actigraphy (Nights 6-7)
Hide Description Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 28 28 29
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time asleep
85.79  (1.117) 83.46  (1.086) 81.38  (1.081) 82.72  (1.089)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.610
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
22.Secondary Outcome
Title Sleep Efficiency Measured by Actigraphy (Nights 13-14)
Hide Description Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 27 30 27
Least Squares Mean (Standard Error)
Unit of Measure: percentage of time asleep
84.98  (1.349) 82.91  (1.381) 81.31  (1.300) 83.24  (1.388)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.352
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.860
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.297
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
23.Secondary Outcome
Title Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7)
Hide Description Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 28 28 29
Least Squares Mean (Standard Error)
Unit of Measure: minutes
41.81  (4.404) 51.98  (4.298) 54.70  (4.211) 53.14  (4.223)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.783
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
24.Secondary Outcome
Title Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14)
Hide Description Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 27 30 27
Least Squares Mean (Standard Error)
Unit of Measure: minutes
48.11  (4.074) 54.72  (4.185) 52.36  (3.874) 51.32  (4.140)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.566
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.543
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.847
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
25.Secondary Outcome
Title Wake Bouts Measured by Actigraphy (Nights 6-7)
Hide Description The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 28 28 29
Least Squares Mean (Standard Error)
Unit of Measure: wake bouts
20.98  (1.518) 22.91  (1.476) 23.32  (1.457) 22.82  (1.442)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.964
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.799
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
26.Secondary Outcome
Title Wake Bouts Measured by Actigraphy (Nights 13-14)
Hide Description The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 27 30 27
Least Squares Mean (Standard Error)
Unit of Measure: wake bouts
23.42  (1.201) 24.21  (1.230) 23.52  (1.146) 22.78  (1.206)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.385
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.641
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
27.Secondary Outcome
Title Sleep Latency Measured by Actigraphy (Nights 6-7)
Hide Description The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 28 28 29
Least Squares Mean (Standard Error)
Unit of Measure: minutes
12.53  (3.292) 18.05  (3.280) 25.00  (3.156) 12.42  (3.129)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
28.Secondary Outcome
Title Sleep Latency Measured by Actigraphy (Nights 13-14)
Hide Description The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 27 30 27
Least Squares Mean (Standard Error)
Unit of Measure: minutes
12.10  (6.145) 16.40  (6.460) 25.43  (5.859) 12.36  (6.169)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.975
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.639
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
29.Secondary Outcome
Title Sleep Time Measured by Actigraphy (Nights 6-7)
Hide Description Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 28 28 29
Least Squares Mean (Standard Error)
Unit of Measure: hours on a 24-hour clock
23.28  (0.150) 22.75  (0.150) 23.11  (0.150) 23.31  (0.150)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.823
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.296
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
30.Secondary Outcome
Title Sleep Time Measured by Actigraphy (Nights 13-14)
Hide Description Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 27 30 27
Least Squares Mean (Standard Error)
Unit of Measure: hours on a 24-hour clock
22.83  (0.150) 22.71  (0.166) 23.11  (0.150) 23.18  (0.150)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.732
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
31.Secondary Outcome
Title Wake Time Measured by Actigraphy (Nights 6-7)
Hide Description Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 28 28 29
Least Squares Mean (Standard Error)
Unit of Measure: hours on a 24-hour clock
06.20  (0.116) 06.18  (0.116) 06.23  (0.116) 06.36  (0.116)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.298
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.430
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
32.Secondary Outcome
Title Wake Time Measured by Actigraphy (Nights 13-14)
Hide Description Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 26 27 30 27
Least Squares Mean (Standard Error)
Unit of Measure: hours on a 24-hour clock
06.13  (0.133) 06.08  (0.133) 06.16  (0.133) 06.30  (0.133)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.349
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.203
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
33.Secondary Outcome
Title Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7)
Hide Description Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long do you think it took you to fall asleep last night?”
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 34 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
103.55  (8.301) 84.46  (8.087) 92.79  (7.930) 97.28  (8.491)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.581
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
34.Secondary Outcome
Title Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14)
Hide Description Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long do you think it took you to fall asleep last night?”
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 28 29 32 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
80.57  (7.406) 69.40  (7.423) 77.29  (7.178) 74.75  (7.407)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.595
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.795
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
35.Secondary Outcome
Title Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)
Hide Description Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long (total hours and minutes) do you think you slept last night?”
Time Frame Nights 6-7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
Arm/Group Title Ramelteon 1 mg QD Ramelteon 4 mg QD Ramelteon 8 mg QD Placebo QD
Hide Arm/Group Description:
Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
Overall Number of Participants Analyzed 31 33 34 30
Least Squares Mean (Standard Error)
Unit of Measure: minutes
348.10  (10.302) 370.14  (10.067) 360.57  (9.883) 341.76  (10.571)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramelteon 1 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.655
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ramelteon 8 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ramelteon 4 mg QD, Placebo QD
Comments The comparison between the 2 treatment groups was made using the ANCOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments Statistical significance was determined at the 0.05 level.
Method ANCOVA
Comments LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.
36.Secondary Outcome
Title Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)
Hide Description Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, “How long (total hours and minutes) do you think you slept last night?”
Time Frame Nights 13-14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.