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

Sponsor
Sunovion (Industry)
Overall Status
Completed
CT.gov ID
NCT00386334
Collaborator
(none)
388
Enrollment
82
Locations
2
Arms
16
Duration (Months)
4.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

A double-blind, randomized, placebo controlled, parallel group study of eszopiclone in elderly subjects with primary chronic insomnia. The study will involve up to 9 visits and subject participation will be approximately 18 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Design

Study Type:
Interventional
Actual Enrollment :
388 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Feb 1, 2008
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Week -2 to day 0 single blind one tablet placebo in the evening. Double blind period: Day 1 to Week 12 double blind one tablet placebo in the evening. Follow up period: two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.

Drug: Placebo
Tablet one per day in the evening.
Experimental: Eszopiclone

Week -2 to day 0 single blind one tablet placebo in evening. Double Blind period: Day 1 to Week 12 double blind one tablet 2 mg of eszopiclone in evening. Follow up period consists of two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.

Drug: Eszopiclone
2 mg tablet once per day in the evening
Other Names:
  • Lunesta

    • Drug: Placebo
    Tablet one per day in the evening.

    Outcome Measures

    Primary Outcome Measures

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

      The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.

    Secondary Outcome Measures

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

      The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.

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

      The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).

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

      Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.

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

      Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).

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

      Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.

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

      Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).

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

      The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).

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

      Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).

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

      Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).

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

      Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).

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

      Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values).

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

      Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values).

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

      Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).

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

      Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).

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

      Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).

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

      Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.

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

      Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).

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

      Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.

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

      Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.

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

      Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values).

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

      Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.

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

      Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.

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

      Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.

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

      Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.

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

      Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.

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

      Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).

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

      Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.

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

      Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.

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

      Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).

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

      Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.

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

      Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.

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

      The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).

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

      Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.

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

      Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.

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

      The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).

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

      Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.

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

      Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.

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

      The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).

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

      Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.

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

      Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.

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

      The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).

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

      Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.

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

      This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).

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

      Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.

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

      This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16).

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

      Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.

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

      Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.
    Exclusion Criteria:
    • Subject has recent history of known clinically significant abnormal laboratory findings.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35226
    2 Chandler Arizona United States 85225
    3 Glendale Arizona United States 85306
    4 Tucson Arizona United States 85712
    5 Anaheim California United States 92801
    6 Irvine California United States 92618
    7 La Mesa California United States 91942
    8 Los Angeles California United States 90024
    9 San Diego California United States 92108
    10 San Diego California United States 92121
    11 San Diego California United States 92123
    12 Colorado Springs Colorado United States 80918
    13 Denver Colorado United States 80212
    14 Atlanta Florida United States 30342
    15 Clearwater Florida United States 33765
    16 Coral Springs Florida United States 33065
    17 Delray Beach Florida United States 33458
    18 Ft. Myers Florida United States 33912
    19 Gables Florida United States 33134
    20 Jupiter Florida United States 33458
    21 Maitland Florida United States 32751
    22 Naples Florida United States 34110
    23 Orlando Florida United States 32806
    24 Pembroke Pines Florida United States 33024
    25 Pinellas Park Florida United States 33781
    26 Sarasota Florida United States 34238
    27 St. Petersburg Florida United States 33707
    28 St. Petersburg Florida United States 33709
    29 Vero Beach Florida United States 32960
    30 West Palm Beach Florida United States 33407
    31 Stockbridge Georgia United States 30281
    32 Honolulu Hawaii United States 96814
    33 Chicago Illinois United States 60610
    34 Chicago Illinois United States 60634
    35 Vernon Hills Illinois United States 60061
    36 Evansville Indiana United States 47714
    37 Overland Park Kansas United States 66212
    38 Prairie Village Kansas United States 66206
    39 Crestview Hills Kentucky United States 41017
    40 Lexington Kentucky United States 40509
    41 Baton Rouge Louisiana United States 70809
    42 Baltimore Maryland United States 21208
    43 Boston Massachusetts United States 02135
    44 Braintree Massachusetts United States 02184
    45 Newton Massachusetts United States 02459
    46 Florissant Missouri United States 63031
    47 Hamilton New Jersey United States 08690
    48 Albuquerque New Mexico United States 87106
    49 Brooklyn New York United States 11235
    50 Mineola New York United States 11501
    51 New York New York United States 10021
    52 New York New York United States 10023
    53 Rochester New York United States 14609
    54 Cary North Carolina United States 27540
    55 Durham North Carolina United States 27710
    56 Hickory North Carolina United States 28601
    57 New Bern North Carolina United States 28562
    58 Winston-Salem North Carolina United States 27157
    59 Beachwood Ohio United States 44122
    60 Cincinnati Ohio United States 45206
    61 Cleveland Ohio United States 44122
    62 Dayton Ohio United States 45408
    63 Mogadore Ohio United States 44260
    64 Oklahoma City Oklahoma United States 73103
    65 Oklahoma City Oklahoma United States 73112
    66 Oklahoma City Oklahoma United States 73118
    67 Allentown Pennsylvania United States 18104
    68 Duncansville Pennsylvania United States 16635
    69 Scotland Pennsylvania United States 17254
    70 Warwick Rhode Island United States 02886
    71 Anderson Pharmaceutical Research Anderson South Carolina United States 29521
    72 Anderson South Carolina United States 29621
    73 Simpsonville South Carolina United States 29681
    74 Dallas Texas United States 75231
    75 Houston Texas United States 77024
    76 San Antonio Texas United States 78205
    77 San Antonio Texas United States 78229
    78 San Antonio Texas United States 78238
    79 Wichita Falls Texas United States 76309
    80 Fairfax Virginia United States 22030
    81 Richmond Virginia United States 23229
    82 Spokane Washington United States 99204

    Sponsors and Collaborators

    • Sunovion

    Investigators

    • Study Chair: Medical Director, CNS, Sunovion

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT00386334
    Other Study ID Numbers:
    • 190-904
    First Posted:
    Oct 11, 2006
    Last Update Posted:
    Mar 14, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Sunovion
    insomnia
    chronic
    primary
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Eszopiclone

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 823 participants were screened. Two participants in each arm completed all assessments for the double blind period but discontinued before starting the follow up period (withdrew consent; did not take any single blind medication in follow up period).
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Period Title: Double Blind Period
    STARTED 194 194
    COMPLETED 148 147
    NOT COMPLETED 46 47
    Period Title: Double Blind Period
    STARTED 146 145
    COMPLETED 143 144
    NOT COMPLETED 3 1

    Baseline Characteristics

    Arm/Group Title Placebo Eszopiclone Total
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets Total of all reporting groups
    Overall Participants 194 194 388
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    194
    100%
    194
    100%
    388
    100%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    72.4
    (5.2)
    71.6
    (5.0)
    72.0
    (5.1)
    Sex: Female, Male (Count of Participants)
    Female
    119
    61.3%
    124
    63.9%
    243
    62.6%
    Male
    75
    38.7%
    70
    36.1%
    145
    37.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    0.5%
    1
    0.3%
    Asian
    2
    1%
    4
    2.1%
    6
    1.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    1
    0.5%
    1
    0.3%
    Black or African American
    9
    4.6%
    8
    4.1%
    17
    4.4%
    White
    181
    93.3%
    178
    91.8%
    359
    92.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    2
    1%
    2
    1%
    4
    1%
    Region of Enrollment (participants) [Number]
    United States
    194
    100%
    194
    100%
    388
    100%
    Body Mass Index (BMI) (Kilograms/Meters squared) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Kilograms/Meters squared]
    27.28
    (4.98)
    28.25
    (4.90)
    27.76
    (4.96)
    Height (Centimeters) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Centimeters]
    165.90
    (9.83)
    164.70
    (10.04)
    165.30
    (9.94)
    Weight (kilograms) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms]
    75.44
    (17.07)
    76.98
    (16.72)
    76.21
    (16.89)

    Outcome Measures

    1. Primary Outcome
    Title Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.
    Description The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose)-12 weeks

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 191 191
    Mean (Standard Deviation) [minutes]
    33.18
    (50.02)
    63.24
    (52.76)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    2. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
    Description The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.
    Time Frame Weeks 0, 3, 6, 9, 12, 14, 16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=191,190)
    20.65
    (42.34)
    51.02
    (46.43)
    Week 6 (n=191,191)
    32.47
    (53.31)
    61.91
    (54.15)
    Week 9 (n=191,191)
    38.73
    (57.73)
    69.00
    (61.58)
    Week 12 (n=191,191)
    40.86
    (60.74)
    70.97
    (62.18)
    Week 14 (n=191,191)
    42.78
    (66.52)
    50.12
    (68.25)
    Week 16 (n=191,191)
    37.43
    (67.68)
    47.17
    (63.68)
    3. Secondary Outcome
    Title Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
    Description The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0, 3, 6, 9, 12, 14, 16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,191)
    294.03
    (63.30)
    297.86
    (56.14)
    Week 3 (n=192,192)
    314.53
    (63.52)
    347.37
    (57.17)
    Week 6 (n=192,193)
    326.25
    (65.41)
    358.72
    (61.47)
    Week 9 (n=192,193)
    332.47
    (65.25)
    365.80
    (64.97)
    Week 12 (n=192,193)
    334.69
    (69.91)
    367.75
    (66.08)
    Weeks 3,6,9,12 (double blind average)(n=192,193)
    326.98
    (62.88)
    360.08
    (59.40)
    Week 14 (n=192,193)
    336.55
    (71.13)
    347.12
    (72.97)
    Week 16 (n=192,193)
    331.29
    (72.53)
    344.20
    (74.91)
    4. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.
    Description Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - Week12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 191 191
    Mean (Standard Deviation) [minutes]
    -19.92
    (46.99)
    -24.62
    (46.32)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0014
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    5. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
    Description Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=191,190)
    -13.34
    (41.97)
    -21.89
    (44.38)
    Week 6 (n=191,191)
    -19.69
    (52.08)
    -24.13
    (49.20)
    Week 9 (n=191,191)
    -23.02
    (50.75)
    -24.21
    (52.62)
    Week 12 (n=191,191)
    -23.54
    (54.14)
    -28.35
    (49.72)
    Week 14 (n=191,191)
    -25.08
    (58.99)
    -17.00
    (55.55)
    Week 16 (n=191,191)
    -24.61
    (55.22)
    -18.73
    (51.67)
    6. Secondary Outcome
    Title Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
    Description Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,191)
    82.17
    (74.08)
    75.68
    (56.63)
    Week 3 (n=192,192)
    68.80
    (64.51)
    54.69
    (46.16)
    Week 6 (n=192,193)
    62.57
    (60.06)
    52.11
    (48.66)
    Week 9 (n=192,193)
    59.23
    (52.05)
    51.75
    (51.79)
    Week 12 (n=192,193)
    58.69
    (51.84)
    47.66
    (39.70)
    Weeks 3,6,9,12 (double blind average)(n=192,193)
    62.32
    (54.82)
    51.51
    (43.87)
    Week 14 (n=192,193)
    57.23
    (49.94)
    58.89
    (45.89)
    Week 16 (n=192,193)
    57.62
    (51.99)
    57.17
    (45.40)
    7. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.
    Description Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) -week 12

    Outcome Measure Data

    Analysis Population Description
    Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 189 191
    Mean (Standard Deviation) [minutes]
    -14.75
    (38.45)
    -36.40
    (41.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    8. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
    Description Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=188,190)
    -8.55
    (35.80)
    -29.26
    (37.68)
    Week 6 (n=189,191)
    -13.46
    (39.01)
    -36.57
    (43.11)
    Week 9 (n=189,191)
    -17.67
    (44.13)
    -40.32
    (45.12)
    Week 12 (n=189,191)
    -19.13
    (43.39)
    -39.61
    (46.48)
    Week 14 (n=189,191)
    -22.72
    (45.00)
    -32.27
    (47.55)
    Week 16 (n=189,191)
    -20.18
    (48.06)
    -31.13
    (51.35)
    9. Secondary Outcome
    Title Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
    Description Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=190,191)
    90.86
    (51.77)
    92.66
    (58.11)
    Week 3 (n=190,192)
    83.17
    (49.63)
    64.33
    (45.97)
    Week 6 (n=192,193)
    77.86
    (48.82)
    56.49
    (44.25)
    Week 9 (n=192,193)
    73.33
    (49.71)
    52.75
    (42.51)
    Week 12 (n=192,193)
    72.02
    (50.44)
    53.45
    (44.23)
    Weeks 3,6,9,12 (double blind average)(n=192,193)
    76.59
    (47.52)
    56.68
    (42.40)
    Week 14 (n=192,193)
    68.39
    (51.87)
    60.71
    (47.07)
    Week 16 (n=192,193)
    71.27
    (54.61)
    61.84
    (48.93)
    10. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.
    Description The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - Week12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 189 191
    Mean (Standard Deviation) [number of awakenings]
    -0.27
    (0.72)
    -0.56
    (0.79)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments Multiple comparisons not applied due to only two treatments in study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    11. Secondary Outcome
    Title Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
    Description The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=188,190)
    -0.16
    (.63)
    -0.46
    (0.70)
    Week 6 (n=189,191)
    -0.24
    (0.77)
    -0.56
    (0.83)
    Week 9 (n=189,191)
    -0.33
    (0.81)
    -0.57
    (0.88)
    Week 12 (n=189,191)
    -0.35
    (0.83)
    -0.65
    (0.90)
    Week 14 (n=189,191)
    -0.38
    (0.85)
    -0.46
    (0.96)
    Week 16 (n=189,191)
    -0.35
    (0.87)
    -0.44
    (0.97)
    12. Secondary Outcome
    Title Mean Number of Awakenings (Subject-reported) at Various Study Time Points
    Description Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=190,191)
    1.95
    (1.00)
    2.10
    (1.10)
    Week 3 (n=190,192)
    1.78
    (0.91)
    1.66
    (0.96)
    Week 6 (n=192,193)
    1.72
    (0.93)
    1.55
    (1.00)
    Week 9 (n=192,193)
    1.62
    (0.94)
    1.54
    (1.01)
    Week 12 (n=192,193)
    1.61
    (0.94)
    1.46
    (1.03)
    Weeks 3,6,9,12 (double blind average)(n=192,193)
    1.68
    (0.90)
    1.55
    (0.97)
    Week 14 (n=192,193)
    1.58
    (0.99)
    1.65
    (1.15)
    Week 16 (n=192,193)
    1.61
    (0.97)
    1.66
    (1.11)
    13. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period
    Description Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - Week12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 189 191
    Mean (Standard Deviation) [units on a scale]
    0.68
    (1.35)
    1.39
    (1.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    14. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
    Description Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=188,190)
    0.37
    (0.98)
    1.12
    (1.18)
    Week 6 (n=189,191)
    0.62
    (1.31)
    1.35
    (1.43)
    Week 9 (n=189,191)
    0.81
    (1.58)
    1.52
    (1.62)
    Week 12 (n=189,191)
    0.92
    (1.77)
    1.57
    (1.73)
    Week 14 (n=189,191)
    1.02
    (1.88)
    1.26
    (2.07)
    Week 16 (n=189, 191)
    0.88
    (1.96)
    1.22
    (2.06)
    15. Secondary Outcome
    Title Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
    Description Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=190,191)
    4.84
    (1.83)
    4.68
    (1.94)
    Week 3 (n=190,190)
    5.22
    (1.62)
    5.77
    (1.82)
    Week 6 (n=192,193)
    5.48
    (1.56)
    6.01
    (1.77)
    Week 9 (n=192,193)
    5.67
    (1.57)
    6.17
    (1.71)
    Week 12 (n=192,193)
    5.78
    (1.58)
    6.22
    (1.70)
    Weeks 3,6,9,12 (double blind average)(n=192, 193)
    5.54
    (1.50)
    6.04
    (1.68)
    Week 14 (n=192,193)
    5.88
    (1.60)
    5.91
    (1.76)
    Week 16 (n=192,193)
    5.73
    (1.65)
    5.88
    (1.75)
    16. Secondary Outcome
    Title Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.
    Description Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 188 190
    Mean (Standard Deviation) [units on a scale]
    0.69
    (1.33)
    1.33
    (1.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    17. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
    Description Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=188, 190)
    0.40
    (0.97)
    1.07
    (1.16)
    Week 6 (n=189, 191)
    0.62
    (1.29)
    1.30
    (1.44)
    Week 9 (n=189, 191)
    0.82
    (1.54)
    1.46
    (1.63)
    Week 12 (n=189, 191)
    0.93
    (1.74)
    1.49
    (1.73)
    Week 14 (n=189,191)
    1.00
    (1.88)
    1.23
    (2.08)
    Week 16 (n=189,191)
    0.88
    (1.96)
    1.15
    (2.05)
    18. Secondary Outcome
    Title Mean Subject-reported Depth of Sleep at Various Study Time Points
    Description Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=190,191)
    4.87
    (1.88)
    4.72
    (1.90)
    Week 3 (n=190,192)
    5.29
    (1.62)
    5.76
    (1.78)
    Week 6 (n=192,193)
    5.51
    (1.58)
    6.00
    (1.75)
    Week 9 (n=192,193)
    5.71
    (1.58)
    6.15
    (1.73)
    Week 12 (n=192, 193)
    5.82
    (1.59)
    6.18
    (1.70)
    Weeks 3,6,9,12 (double blind average)(n=192,193)
    5.58
    (1.52)
    6.02
    (1.68)
    Week 14 (n=192,193)
    5.89
    (1.63)
    5.92
    (1.78)
    Week 16 (n=192,193)
    5.76
    (1.69)
    5.84
    (1.76)
    19. Secondary Outcome
    Title Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period
    Description Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 189 192
    Mean (Standard Deviation) [units on a scale]
    0.61
    (1.30)
    1.02
    (1.31)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    20. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
    Description Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=189,191)
    0.39
    (0.90)
    0.76
    (1.03)
    Week 6 (n=189,192)
    0.55
    (1.28)
    0.99
    (1.29)
    Week 9 (n=189,192)
    0.72
    (1.53)
    1.10
    (1.54)
    Week 12 (n=189,192)
    0.78
    (1.72)
    1.21
    (1.64)
    Week 14 (n=189,192)
    0.85
    (1.81)
    1.05
    (1.92)
    Week 16 (n=189,192)
    0.78
    (1.89)
    0.97
    (2.00)
    21. Secondary Outcome
    Title Mean Subject-reported Daytime Alertness at Various Study Time Points.
    Description Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,193)
    5.34
    (1.97)
    5.42
    (2.11)
    Week 3 (n=190,191)
    5.74
    (1.72)
    6.18
    (1.78)
    Week 6 (n=190,192)
    5.89
    (1.57)
    6.41
    (1.68)
    Week 9 (n=190,192)
    6.06
    (1.51)
    6.52
    (1.59)
    Week 12 (n=190,192)
    6.13
    (1.51)
    6.64
    (1.58)
    Weeks 3,6,9,12 (double blind average)(n=190,192)
    5.95
    (1.50)
    6.44
    (1.59)
    Week 14 (n=190,192)
    6.19
    (1.52)
    6.47
    (1.63)
    Week 16 (n=190,192)
    6.13
    (1.59)
    6.39
    (1.60)
    22. Secondary Outcome
    Title Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period
    Description Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 189 192
    Mean (Standard Deviation) [units on a scale]
    0.53
    (1.29)
    0.91
    (1.28)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    23. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
    Description Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=189,191)
    0.36
    (0.88)
    0.69
    (0.98)
    Week 6 (n=189,192)
    0.46
    (1.25)
    0.87
    (1.27)
    Week 9 (n=189,192)
    0.62
    (1.54)
    0.98
    (1.50)
    Week 12 (n=189,192)
    0.69
    (1.68)
    1.08
    (1.60)
    Week 14 (n=189,192)
    0.75
    (1.81)
    0.96
    (1.87)
    Week 16 (n=189,192)
    0.69
    (1.87)
    0.87
    (1.96)
    24. Secondary Outcome
    Title Mean Subject-reported Ability to Function at Various Study Time Points
    Description Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,193)
    5.62
    (2.07)
    5.69
    (2.14)
    Week 3 (n=190,191)
    5.98
    (1.79)
    6.38
    (1.79)
    Week 6 (n=190,192)
    6.09
    (1.61)
    6.57
    (1.68)
    Week 9 (n=190,192)
    6.24
    (1.56)
    6.69
    (1.57)
    Week 12 (n=190,192)
    6.32
    (1.54)
    6.79
    (1.55)
    Weeks 3,6,9,12 (double blind average)(n=190,192)
    6.16
    (1.55)
    6.61
    (1.59)
    Week 14 (n=190,192)
    6.38
    (1.54)
    6.66
    (1.57)
    Week 16 (n=190,192)
    6.31
    (1.62)
    6.57
    (1.57)
    25. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.
    Description Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseliine (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 189 192
    Mean (Standard Deviation) [units on a scale]
    0.50
    (1.30)
    0.96
    (1.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    26. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
    Description Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=189,191)
    0.32
    (0.89)
    0.73
    (0.96)
    Week 6 (n=189,192)
    0.43
    (1.29)
    0.93
    (1.24)
    Week 9 (n=189,192)
    0.60
    (1.53)
    1.03
    (1.48)
    Week 12 (n=189,192)
    0.66
    (1.71)
    1.14
    (1.57)
    Week 14 (n=189,192)
    0.72
    (1.81)
    1.00
    (1.87)
    Week 16 (n=189,192)
    0.66
    (1.89)
    0.93
    (1.93)
    27. Secondary Outcome
    Title Mean Subject-reported Ability to Concentrate at Various Study Time Points
    Description Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,193)
    5.66
    (2.08)
    5.63
    (2.15)
    Week 3 (n=190,191)
    5.99
    (1.78)
    6.37
    (1.80)
    Week 6 (n=190,192)
    6.10
    (1.62)
    6.57
    (1.69)
    Week 9 (n=190,192)
    6.27
    (1.54)
    6.67
    (1.58)
    Week 12 (n=190,192)
    6.33
    (1.52)
    6.77
    (1.57)
    Weeks 3,6,9,12 (double blind average)(n=190,192)
    6.17
    (1.54)
    6.60
    (1.60)
    Week 14 (n=190,192)
    6.39
    (1.53)
    6.64
    (1.58)
    Week 16 (n=190,192)
    6.33
    (1.61)
    6.56
    (1.59)
    28. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period
    Description Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 189 192
    Mean (Standard Deviation) [units on a scale]
    0.52
    (1.28)
    0.87
    (1.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    29. Secondary Outcome
    Title Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
    Description Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=189,191)
    0.35
    (0.88)
    0.68
    (0.99)
    Week 6 (n=189,192)
    0.46
    (1.26)
    0.84
    (1.27)
    Week 9 (n=189,192)
    0.61
    (1.52)
    0.93
    (1.51)
    Week 12 (n=189,192)
    0.65
    (1.71)
    1.02
    (1.62)
    Week 14 (n=189,192)
    0.72
    (1.82)
    0.89
    (1.92)
    Week 16 (n=189,192)
    0.64
    (1.90)
    0.80
    (1.97)
    30. Secondary Outcome
    Title Mean Subject-reported Physical Well-Being at Various Study Time Points
    Description Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,193)
    5.45
    (1.98)
    5.62
    (2.14)
    Week 3 (n=190,191)
    5.80
    (1.74)
    6.30
    (1.77)
    Week 6 (n=190,192)
    5.92
    (1.57)
    6.46
    (1.65)
    Week 9 (n=190,192)
    6.06
    (1.53)
    6.56
    (1.56)
    Week 12 (n=190,192)
    6.11
    (1.52)
    6.65
    (1.53)
    Weeks 3,6,9,12 (double blind average)(n=190,192)
    5.97
    (1.51)
    6.49
    (1.56)
    Week 14 (n=190,192)
    6.18
    (1.53)
    6.51
    (1.56)
    Week 16 (n=190,192)
    6.09
    (1.61)
    6.43
    (1.56)
    31. Secondary Outcome
    Title Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period
    Description Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose)- week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 110 93
    Mean (Standard Deviation) [number of naps]
    -0.78
    (2.30)
    -1.23
    (2.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1175
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    32. Secondary Outcome
    Title Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
    Description Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=110,92)
    -0.39
    (2.04)
    -1.15
    (2.02)
    Week 6 (n=110,93)
    -0.80
    (2.49)
    -1.26
    (2.21)
    Week 9 (n=110, 93)
    -0.96
    (2.67)
    -1.33
    (2.51)
    Week 12 (n=110, 93)
    -0.96
    (2.88)
    -1.18
    (2.58)
    Week 14 (n=110,93)
    -0.71
    (2.93)
    -1.00
    (2.31)
    Week 16 (n=110,93)
    -0.92
    (2.79)
    -1.29
    (2.49)
    33. Secondary Outcome
    Title Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
    Description The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=111,94)
    4.03
    (4.41)
    3.88
    (3.55)
    Week 3 (n=110,92)
    3.67
    (4.67)
    2.76
    (2.96)
    Week 6 (n=110,93)
    3.26
    (4.25)
    2.64
    (3.00)
    Week 9 (n=110,93)
    3.10
    (4.57)
    2.57
    (2.63)
    Week 12 (n=110,93)
    3.10
    (5.05)
    2.71
    (3.06)
    Weeks 3,6,9,12 (double blind average)(n=110,93)
    3.28
    (4.51)
    2.66
    (2.74)
    Week 14 (n=110,93)
    3.35
    (5.32)
    2.90
    (3.12)
    Week 16 (n=110,93)
    3.14
    (4.63)
    2.61
    (3.15)
    34. Secondary Outcome
    Title Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period
    Description Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 110 93
    Mean (Standard Deviation) [minutes]
    -36.02
    (125.59)
    -60.06
    (156.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0717
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    35. Secondary Outcome
    Title Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
    Description Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=110,92)
    -21.66
    (116.53)
    -59.06
    (158.00)
    Week 6 (n=110,93)
    -40.02
    (140.47)
    -65.99
    (163.12)
    Week 9 (n=110,93)
    -40.25
    (146.42)
    -56.59
    (184.47)
    Week 12 (n=110,93)
    -42.15
    (136.85)
    -58.22
    (163.87)
    Week 14 (n=110,93)
    -27.28
    (142.36)
    -44.48
    (165.67)
    Week 16 (n=110,93)
    -38.14
    (137.69)
    -49.15
    (202.13)
    36. Secondary Outcome
    Title Mean Subject-Reported Total Nap Time at Various Study Time Points
    Description The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=111,94)
    189.31
    (262.08)
    171.62
    (237.75)
    Week 3 (n=110,92)
    169.24
    (253.66)
    114.43
    (151.26)
    Week 6 (n=110,93)
    150.88
    (226.90)
    106.99
    (133.85)
    Week 9 (n=110,93)
    150.65
    (234.11)
    116.39
    (156.42)
    Week 12 (n=110,93)
    148.75
    (256.87)
    114.76
    (149.73)
    Weeks 3,6,9,12 (double blind average)(n=110,93)
    154.88
    (237.82)
    112.92
    (135.34)
    Week 14 (n=110,93)
    163.61
    (274.13)
    128.50
    (173.51)
    Week 16 (n=110,93)
    152.76
    (246.50)
    123.83
    (173.58)
    37. Secondary Outcome
    Title Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period
    Description Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 110 93
    Mean (Standard Deviation) [percentage of total asleep time]
    -2.44
    (8.29)
    -2.98
    (5.53)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1182
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments
    38. Secondary Outcome
    Title Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
    Description Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=110,92)
    -1.78
    (7.00)
    -2.77
    (5.57)
    Week 6 (n=110,93)
    -2.52
    (9.09)
    -3.16
    (5.80)
    Week 9 (n=110,93)
    -2.72
    (9.26)
    -2.94
    (6.24)
    Week 12 (n=110,93)
    -2.76
    (8.98)
    -3.04
    (5.82)
    Week 14 (n=110,93)
    -2.31
    (9.22)
    -2.14
    (5.82)
    Week 16 (n=110,93)
    -2.55
    (8.62)
    -2.38
    (6.72)
    39. Secondary Outcome
    Title Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
    Description Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=111,94)
    9.05
    (13.89)
    7.02
    (8.34)
    Week 3 (n=110,92)
    7.35
    (11.94)
    4.33
    (5.53)
    Week 6 (n=110,93)
    6.61
    (11.73)
    3.91
    (4.83)
    Week 9 (n=110,93)
    6.41
    (11.04)
    4.13
    (5.15)
    Week 12 (n=110,93)
    6.37
    (11.77)
    4.04
    (5.00)
    Weeks 3,6,9,12 (double blind average)(n=110,93)
    6.68
    (11.37)
    4.09
    (4.75)
    Week 14 (n=110,93)
    6.82
    (11.17)
    4.93
    (6.19)
    Week 16 (n=110,93)
    6.57
    (11.00)
    4.69
    (6.27)
    40. Secondary Outcome
    Title Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
    Description Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 62 61
    Mean (Standard Deviation) [minutes]
    14.40
    (38.14)
    17.96
    (34.71)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3010
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    41. Secondary Outcome
    Title Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
    Description Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.
    Time Frame Baseline (week 0), Weeks 1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 1 (n=60,58)
    3.72
    (54.09)
    14.97
    (36.91)
    Week 4 (n=61,61)
    17.21
    (39.97)
    16.89
    (41.00)
    Week 7 (n=62,61)
    15.72
    (57.85)
    22.12
    (41.02)
    Week 12 (n=62,61)
    18.93
    (44.73)
    18.08
    (52.57)
    Week 13 (n=62,61)
    15.36
    (51.72)
    -0.60
    (56.17)
    Week 15 (n=62,61)
    13.82
    (43.48)
    4.06
    (47.60)
    42. Secondary Outcome
    Title Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
    Description Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values).
    Time Frame Weeks 0,1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 0 (n=64,61)
    351.06
    (86.05)
    367.95
    (60.86)
    Week 1 (n=64,64)
    354.11
    (94.76)
    381.52
    (73.83)
    Week 4 (n=67,67)
    366.69
    (78.34)
    382.39
    (69.41)
    Week 7 (n=68,67)
    368.58
    (86.48)
    386.96
    (63.89)
    Week 12 (n=68,67)
    368.70
    (83.39)
    382.04
    (69.98)
    Weeks 1,4,7,12 (double blind average)(n=68,67)
    365.13
    (79.31)
    383.30
    (63.78)
    Week 13 (n=68,67)
    366.47
    (81.33)
    364.87
    (74.16)
    Week 15 (n=68,67)
    365.73
    (74.47)
    369.23
    (64.82)
    43. Secondary Outcome
    Title Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
    Description Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 62 61
    Mean (Standard Deviation) [minutes]
    0.00
    (40.75)
    1.47
    (26.76)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7800
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    44. Secondary Outcome
    Title Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
    Description Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
    Time Frame Baseline (week 0), Weeks 1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 1 (n=60,58)
    9.06
    (74.76)
    -0.25
    (18.92)
    Week 4 (n=61,61)
    -2.16
    (44.61)
    -1.48
    (27.74)
    Week 7 (n=62,61)
    0.12
    (52.95)
    -1.62
    (26.28)
    Week 12 (n=62,61)
    -3.92
    (36.22)
    9.34
    (57.32)
    Week 13 (n=62,61)
    -0.69
    (59.32)
    16.13
    (66.04)
    Week 15 (n=62,61)
    -3.66
    (39.21)
    6.44
    (36.59)
    45. Secondary Outcome
    Title Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
    Description Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.
    Time Frame Weeks 0,1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) & average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 0 (n=64,61)
    31.34
    (65.06)
    23.89
    (24.50)
    Week 1 (n=64,64)
    37.74
    (78.14)
    26.72
    (36.56)
    Week 4 (n=67,67)
    28.55
    (35.46)
    26.62
    (43.36)
    Week 7 (n=68,67)
    31.06
    (42.82)
    26.89
    (33.34)
    Week 12 (n=68,67)
    27.89
    (38.78)
    36.93
    (57.69)
    Weeks 1,4,7,12 (double blind average)(n=68,67)
    31.20
    (36.89)
    29.22
    (35.92)
    Week 13 (n=68,67)
    30.40
    (41.05)
    43.06
    (64.37)
    Week 15 (n=68,67)
    28.80
    (37.75)
    34.35
    (40.34)
    46. Secondary Outcome
    Title Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
    Description Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 62 61
    Mean (Standard Deviation) [minutes]
    4.50
    (19.54)
    -4.24
    (22.91)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0803
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    47. Secondary Outcome
    Title Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
    Description Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
    Time Frame Baseline (week 0), Weeks 1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 1 (n=59,58)
    3.17
    (16.23)
    -6.59
    (23.78)
    Week 4 (n=61,61)
    4.67
    (23.36)
    -3.88
    (26.95)
    Week 7 (n=62,61)
    6.57
    (30.27)
    -4.19
    (25.25)
    Week 12 (n=62,61)
    3.24
    (17.90)
    -2.54
    (24.42)
    Week 13 (n=62,61)
    4.98
    (22.35)
    0.68
    (23.79)
    Week 15 (n=62,61)
    7.74
    (25.70)
    -0.27
    (24.10)
    48. Secondary Outcome
    Title Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
    Description Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).
    Time Frame weeks 0,1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 0 (n=64,61)
    60.27
    (29.51)
    63.75
    (29.11)
    Week 1 (n=63,64)
    63.53
    (31.09)
    55.39
    (22.11)
    Week 4 (n=67,67)
    64.16
    (32.11)
    58.86
    (24.51)
    Week 7 (n=68,67)
    65.81
    (35.11)
    58.09
    (22.41)
    Week 12 (n=68,67)
    62.41
    (30.09)
    60.22
    (23.10)
    Weeks 1,4,7,12 (double blind average)(n=68,67)
    63.69
    (29.90)
    58.21
    (20.76)
    Week 13 (n=68,67)
    64.09
    (31.39)
    63.01
    (27.84)
    Week 15 (n=68,67)
    67.07
    (37.40)
    62.27
    (25.77)
    49. Secondary Outcome
    Title Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
    Description Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 62 61
    Mean (Standard Deviation) [number of awakenings]
    0.87
    (3.65)
    -0.18
    (4.28)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2643
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    50. Secondary Outcome
    Title Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
    Description Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
    Time Frame Baseline (week 0), Weeks 1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 1 (n=59,58)
    0.76
    (3.09)
    -0.54
    (4.19)
    Week 4 (n=61,61)
    0.79
    (4.62)
    0.04
    (5.22)
    Week 7 (n=62,61)
    0.88
    (4.73)
    -0.21
    (5.05)
    Week 12 (n=62,61)
    0.95
    (4.60)
    -0.10
    (4.93)
    Week 13 (n=62,61)
    1.10
    (4.69)
    0.01
    (4.93)
    Week 15 (n=62,61)
    1.36
    (4.35)
    -0.13
    (5.02)
    51. Secondary Outcome
    Title Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
    Description Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
    Time Frame Weeks 0,1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 0 (n=64,61)
    21.49
    (7.53)
    22.84
    (6.94)
    Week 1 (n=63,64)
    22.42
    (7.17)
    21.86
    (5.96)
    Week 4 (n=67,67)
    22.28
    (7.30)
    22.51
    (6.16)
    Week 7 (n=68,67)
    22.52
    (7.93)
    22.19
    (6.08)
    Week 12 (n=68,67)
    22.36
    (7.76)
    22.37
    (6.25)
    Weeks 1,4,7,12 (double blind average)(n=68,67)
    22.40
    (7.15)
    22.27
    (5.66)
    Week 13 (n=68,67)
    22.55
    (7.57)
    22.48
    (7.30)
    Week 15 (n=68,67)
    22.87
    (7.71)
    22.38
    (5.99)
    52. Secondary Outcome
    Title Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
    Description Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 58 58
    Mean (Standard Deviation) [number of naps]
    1.61
    (9.06)
    -2.67
    (12.61)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0765
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    53. Secondary Outcome
    Title Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
    Description Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
    Time Frame Baseline (week 0), Weeks 1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 1 (n=57,55)
    1.33
    (9.15)
    -0.62
    (12.92)
    Week 4 (n=57,58)
    1.02
    (11.73)
    -3.43
    (13.36)
    Week 7 (n=58,58)
    1.68
    (10.63)
    -2.83
    (16.76)
    Week 12 (n=58,58)
    1.86
    (9.83)
    -3.47
    (15.15)
    Week 13 (n=58,58)
    2.73
    (10.54)
    -4.58
    (13.69)
    Week 15 (n=58,58)
    3.41
    (11.22)
    -0.64
    (12.16)
    54. Secondary Outcome
    Title Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
    Description The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
    Time Frame Week 0,1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 0 (n=62,58)
    20.52
    (15.63)
    22.33
    (15.42)
    Week 1 (n=57,55)
    20.94
    (14.99)
    21.69
    (15.38)
    Week 4 (n=57,58)
    20.63
    (15.38)
    18.90
    (13.85)
    Week 7 (n=58,58)
    21.07
    (14.93)
    19.50
    (15.18)
    Week 12 (n=58,58)
    21.25
    (14.29)
    18.86
    (15.18)
    Weeks 1,4,7,12 (double blind average)(n=58,58)
    21.01
    (13.90)
    19.66
    (12.91)
    Week 13 (n=58,58)
    22.12
    (15.97)
    17.75
    (12.66)
    Week 15 (n=58,58)
    22.80
    (15.03)
    21.69
    (14.45)
    55. Secondary Outcome
    Title Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
    Description Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 58 58
    Mean (Standard Deviation) [minutes]
    21.26
    (196.66)
    -40.91
    (307.98)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2967
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    56. Secondary Outcome
    Title Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
    Description Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
    Time Frame Baseline (week 0), Weeks 1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 1 (n=57,55)
    2.37
    (184.85)
    6.56
    (285.45)
    Week 4 (n=57,58)
    6.37
    (252.54)
    -56.87
    (336.01)
    Week 7 (n=58,58)
    23.03
    (220.20)
    -31.85
    (428.85)
    Week 12 (n=58,58)
    38.86
    (229.45)
    -73.67
    (338.69)
    Week 13 (n=58,58)
    64.84
    (275.99)
    -87.50
    (291.01)
    Week 15 (n=58,58)
    61.28
    (235.24)
    -1.99
    (240.85)
    57. Secondary Outcome
    Title Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
    Description The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
    Time Frame Week 0,1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 0 (n=62,58)
    418.49
    (368.31)
    438.02
    (325.66)
    Week 1 (n=57,55)
    399.19
    (298.18)
    445.84
    (358.33)
    Week 4 (n=57,58)
    403.18
    (328.59)
    381.15
    (335.03)
    Week 7 (n=58,58)
    414.68
    (315.20)
    406.16
    (387.87)
    Week 12 (n=58,58)
    430.50
    (313.11)
    364.34
    (313.03)
    Weeks 1,4,7,12 (double blind average)(n=58,58)
    412.91
    (292.66)
    397.11
    (305.65)
    Week 13 (n=58,58)
    456.48
    (352.10)
    350.52
    (262.61)
    Week 15 (n=58,58)
    452.93
    (310.68)
    436.03
    (297.32)
    58. Secondary Outcome
    Title Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.
    Description Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 58 58
    Mean (Standard Deviation) [percentage of total asleep time]
    0.45
    (7.84)
    -1.75
    (8.46)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0634
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    59. Secondary Outcome
    Title Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
    Description Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.
    Time Frame Baseline (week 0), Weeks 1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 1 (n=57,55)
    1.38
    (13.89)
    -0.17
    (7.95)
    Week 4 (n=57,58)
    -0.56
    (8.64)
    -2.14
    (9.54)
    Week 7 (n=58,58)
    0.18
    (9.21)
    -1.75
    (11.22)
    Week 12 (n=58,58)
    0.46
    (7.76)
    -2.70
    (9.24)
    Week 13 (n=58,58)
    0.94
    (7.96)
    -2.63
    (8.98)
    Week 15 (n=58,58)
    0.95
    (8.11)
    -0.04
    (7.41)
    60. Secondary Outcome
    Title Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
    Description The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).
    Time Frame Week 0,1,4,7,12,13,15

    Outcome Measure Data

    Analysis Population Description
    The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 72 69
    Week 0 (n=62,58)
    15.12
    (15.32)
    14.05
    (9.41)
    Week 1 (n=57,55)
    16.29
    (17.55)
    13.89
    (10.19)
    Week 4 (n=57,58)
    14.35
    (13.63)
    11.92
    (9.24)
    Week 7 (n=58,58)
    14.90
    (12.97)
    12.30
    (10.35)
    Week 12 (n=58,58)
    15.18
    (13.23)
    11.36
    (9.14)
    Weeks 1,4,7,12 (double blind average)(n=58,58)
    15.16
    (12.87)
    12.30
    (8.64)
    Week 13 (n=58,58)
    15.66
    (13.84)
    11.43
    (8.28)
    Week 15 (n=58,58)
    15.66
    (12.42)
    14.01
    (8.85)
    61. Secondary Outcome
    Title Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period
    Description Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
    Time Frame Baseline (week 0), Day 1 (post first dose) - week 12

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 180 182
    Mean (Standard Deviation) [units on a scale]
    -3.42
    (4.38)
    -5.67
    (5.26)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Eszopiclone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments Multiple comparisons not applied due to only two treatments in the study.
    Method ANCOVA
    Comments ANCOVA with treatment and site type as fixed effects and the baseline as a covariate
    62. Secondary Outcome
    Title Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
    Description Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.
    Time Frame Baseline (week 0), Weeks 3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 3 (n=179,181)
    -2.74
    (4.51)
    -4.94
    (5.38)
    Week 6 (n=180,181)
    -3.35
    (4.89)
    -5.67
    (5.88)
    Week 9 (n=180,182)
    -3.55
    (5.10)
    -5.89
    (5.88)
    Week 12 (n=180,182)
    -4.05
    (5.15)
    -6.18
    (5.96)
    Week 14 (n=181,182)
    -3.93
    (5.25)
    -4.06
    (5.88)
    Week 16 (n=181,182)
    -2.96
    (5.16)
    -2.96
    (5.24)
    63. Secondary Outcome
    Title Mean Insomnia Severity Index Total Scores at Various Study Time Points
    Description The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
    Time Frame Weeks 0,3,6,9,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,190)
    16.34
    (4.18)
    16.12
    (4.81)
    Week 3 (n=180,183)
    13.52
    (5.11)
    11.09
    (5.48)
    Week 6 (n=181,184)
    12.87
    (5.26)
    10.40
    (5.87)
    Week 9 (n=181,185)
    12.66
    (5.58)
    10.12
    (5.77)
    Week 12 (n=181,185)
    12.16
    (5.51)
    9.84
    (5.63)
    Weeks 3,6,9,12 (double blind average)(n=181,185)
    12.80
    (4.87)
    10.36
    (5.16)
    Week 14 (n=182,185)
    12.30
    (5.68)
    11.94
    (5.56)
    Week 16 (n=182,185)
    13.28
    (5.39)
    13.05
    (5.49)
    64. Secondary Outcome
    Title Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale
    Description Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.
    Time Frame Baseline (week 0), Weeks 6, 12, 16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 6 (n=164,165)
    1.01
    (7.73)
    1.00
    (7.28)
    Week 12 (n=165,166)
    1.38
    (7.60)
    1.01
    (7.14)
    Week 16 (n=166,166)
    0.69
    (7.99)
    0.39
    (6.78)
    65. Secondary Outcome
    Title Mean Physical Component Summary of the Short Form-36 Scale Scores.
    Description This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).
    Time Frame Weeks 0,6,12,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,190)
    43.99
    (10.67)
    45.39
    (9.78)
    Week 6 (n=165,168)
    45.06
    (10.98)
    46.08
    (10.00)
    Week 12 (n=166,169)
    45.38
    (10.57)
    46.12
    (9.42)
    Week 16 (n=167,169)
    44.70
    (10.98)
    45.51
    (9.80)
    66. Secondary Outcome
    Title Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores
    Description Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.
    Time Frame Baseline (week 0), Weeks 6,12,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 6 (n=164,165)
    -0.44
    (7.45)
    0.96
    (8.59)
    Week 12 (n=165,166)
    -0.94
    (8.00)
    0.83
    (8.54)
    Week 16 (n=166,166)
    -1.22
    (8.94)
    0.20
    (7.46)
    67. Secondary Outcome
    Title Mean Mental Component Summary of the Short Form-36 Scale Scores
    Description This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16).
    Time Frame Weeks 0,6,12,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,190)
    49.69
    (9.33)
    49.29
    (10.04)
    Week 6 (n=165,168)
    49.49
    (10.03)
    49.96
    (10.03)
    Week 12 (n=166,169)
    48.98
    (10.19)
    49.86
    (9.09)
    Week 16 (n=167,169)
    48.68
    (10.61)
    49.23
    (9.92)
    68. Secondary Outcome
    Title Mean Change From Baseline in the Sheehan Disability Scale Total Score.
    Description Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.
    Time Frame Baseline (week 0), Weeks 6,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 6 (n=164,165)
    -2.60
    (7.63)
    -4.05
    (7.42)
    Week 12 (n=165,166)
    -3.73
    (7.59)
    -4.48
    (7.72)
    Week 14 (n=166,166)
    -3.11
    (7.88)
    -3.52
    (7.15)
    Week 16 (n=166,166)
    -3.33
    (8.09)
    -2.47
    (7.14)
    69. Secondary Outcome
    Title Mean Sheehan Disability Total Scores
    Description Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16).
    Time Frame Weeks 0,6,12,14,16

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    Measure Participants 194 194
    Week 0 (n=192,190)
    11.38
    (7.80)
    11.13
    (7.63)
    Week 6 (n=165,168)
    8.87
    (6.82)
    7.52
    (6.81)
    Week 12 (n=166,169)
    7.70
    (6.48)
    7.08
    (6.85)
    Week 14 (n=166,166)
    8.37
    (7.21)
    8.03
    (7.10)
    Week 16 (n=167,169)
    8.12
    (7.10)
    9.06
    (7.71)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Placebo Eszopiclone
    Arm/Group Description Placebo tablets Eszopiclone 2 mg tablets
    All Cause Mortality
    Placebo Eszopiclone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Eszopiclone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/ (NaN) 4/ (NaN)
    Gastrointestinal disorders
    Appendicitis Perforated 1/194 (0.5%) 1 0/194 (0%) 0
    Hepatobiliary disorders
    Cholecystisis 0/194 (0%) 0 1/194 (0.5%) 1
    Infections and infestations
    Pneumonia 1/194 (0.5%) 1 0/194 (0%) 0
    Psychiatric disorders
    Completed Suicide 0/194 (0%) 0 1/194 (0.5%) 1
    Renal and urinary disorders
    Stress Urinary Incontinence 0/194 (0%) 0 1/194 (0.5%) 1
    Reproductive system and breast disorders
    Rectocele 0/194 (0%) 0 1/194 (0.5%) 1
    Vascular disorders
    Arteriosclerosis 0/194 (0%) 0 1/194 (0.5%) 1
    Other (Not Including Serious) Adverse Events
    Placebo Eszopiclone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 61/ (NaN) 86/ (NaN)
    Gastrointestinal disorders
    Diarrhoea 1/194 (0.5%) 1 9/194 (4.6%) 13
    Stomach Discomfort 3/194 (1.5%) 7 6/194 (3.1%) 7
    Dry Mouth 4/194 (2.1%) 4 4/194 (2.1%) 5
    Nausea 3/194 (1.5%) 6 4/194 (2.1%) 4
    General disorders
    Fatigue 3/194 (1.5%) 3 5/194 (2.6%) 5
    Pain 3/194 (1.5%) 4 4/194 (2.1%) 5
    Infections and infestations
    Nasopharyngitis 12/194 (6.2%) 13 11/194 (5.7%) 11
    Influenza 5/194 (2.6%) 5 4/194 (2.1%) 4
    Upper Respiratory Tract Infection 3/194 (1.5%) 4 4/194 (2.1%) 4
    Musculoskeletal and connective tissue disorders
    Back Pain 8/194 (4.1%) 8 3/194 (1.5%) 3
    Myalgia 5/194 (2.6%) 6 2/194 (1%) 3
    Arthralgia 1/194 (0.5%) 1 4/194 (2.1%) 6
    Nervous system disorders
    Headache 24/194 (12.4%) 45 27/194 (13.9%) 51
    Dysgeusia 3/194 (1.5%) 4 24/194 (12.4%) 35
    Dizziness 3/194 (1.5%) 3 8/194 (4.1%) 16
    Somnolence 4/194 (2.1%) 5 5/194 (2.6%) 5
    Psychiatric disorders
    Anxiety 2/194 (1%) 2 4/194 (2.1%) 6
    Respiratory, thoracic and mediastinal disorders
    Cough 5/194 (2.6%) 5 5/194 (2.6%) 5
    Pharyngolaryngeal Pain 4/194 (2.1%) 4 5/194 (2.6%) 5
    Skin and subcutaneous tissue disorders
    Rash 4/194 (2.1%) 5 2/194 (1%) 2

    Limitations/Caveats

    The data gathered was subjective (except for actigraphy endpoints) and relied either on self reporting or patient assessments derived from standardized questionnaires.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    In addition to the <60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.

    Results Point of Contact

    Name/Title Lunesta Medical Director
    Organization Sepracor Inc.
    Phone 1-866-503-6351
    Email
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT00386334
    Other Study ID Numbers:
    • 190-904
    First Posted:
    Oct 11, 2006
    Last Update Posted:
    Mar 14, 2016
    Last Verified:
    Feb 1, 2016