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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Insomnia
Interventions:	Drug: Eszopiclone Drug: Placebo

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

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

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

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

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

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

	Description
Placebo	Placebo tablets
Eszopiclone	Eszopiclone 2 mg tablets

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

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

Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

14. Secondary:

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

Show Outcome Measure 14

15. Secondary:

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

Show Outcome Measure 15

16. Secondary:

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

Show Outcome Measure 16

17. Secondary:

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

Show Outcome Measure 17

18. Secondary:

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

Show Outcome Measure 18

19. Secondary:

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

Show Outcome Measure 19

20. Secondary:

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

Show Outcome Measure 20

21. Secondary:

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

Show Outcome Measure 21

22. Secondary:

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

Show Outcome Measure 22

23. Secondary:

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

Show Outcome Measure 23

24. Secondary:

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

Show Outcome Measure 24

25. Secondary:

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

Show Outcome Measure 25

26. Secondary:

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

Show Outcome Measure 26

27. Secondary:

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

Show Outcome Measure 27

28. Secondary:

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

Show Outcome Measure 28

29. Secondary:

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

Show Outcome Measure 29

30. Secondary:

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

Show Outcome Measure 30

31. Secondary:

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

Show Outcome Measure 31

32. Secondary:

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

Show Outcome Measure 32

33. Secondary:

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

Show Outcome Measure 33

34. Secondary:

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

Show Outcome Measure 34

35. Secondary:

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

Show Outcome Measure 35

36. Secondary:

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

Show Outcome Measure 36

37. Secondary:

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

Show Outcome Measure 37

38. Secondary:

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

Show Outcome Measure 38

39. Secondary:

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

Show Outcome Measure 39

40. Secondary:

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

Show Outcome Measure 40

41. Secondary:

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

Show Outcome Measure 41

42. Secondary:

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

Show Outcome Measure 42

43. Secondary:

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

Show Outcome Measure 43

44. Secondary:

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

Show Outcome Measure 44

45. Secondary:

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

Show Outcome Measure 45

46. Secondary:

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

Show Outcome Measure 46

47. Secondary:

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

Show Outcome Measure 47

48. Secondary:

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

Show Outcome Measure 48

49. Secondary:

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

Show Outcome Measure 49

50. Secondary:

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

Show Outcome Measure 50

51. Secondary:

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

Show Outcome Measure 51

52. Secondary:

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

Show Outcome Measure 52

53. Secondary:

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

Show Outcome Measure 53

54. Secondary:

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

Show Outcome Measure 54

55. Secondary:

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

Show Outcome Measure 55

56. Secondary:

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

Show Outcome Measure 56

57. Secondary:

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

Show Outcome Measure 57

58. Secondary:

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

Show Outcome Measure 58

59. Secondary:

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

Show Outcome Measure 59

60. Secondary:

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

Show Outcome Measure 60

61. Secondary:

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

Show Outcome Measure 61

62. Secondary:

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

Show Outcome Measure 62

63. Secondary:

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

Show Outcome Measure 63

64. Secondary:

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

Show Outcome Measure 64

65. Secondary:

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

Show Outcome Measure 65

66. Secondary:

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

Show Outcome Measure 66

67. Secondary:

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

Show Outcome Measure 67

68. Secondary:

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

Show Outcome Measure 68

69. Secondary:

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

Show Outcome Measure 69

More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The data gathered was subjective (except for actigraphy endpoints) and relied either on self reporting or patient assessments derived from standardized questionnaires.

Results Point of Contact:

Name/Title: Lunesta Medical Director
Organization: Sepracor Inc.
phone: 1-866-503-6351

Publications of Results:

Ancoli-Israel S; Krystal AD; McCall WV; Schaefer K; Wilson A; Claus R; Rubens R; Roth T. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. SLEEP 2010;33(2):225-234.

Publications automatically indexed to this study:

Ancoli-Israel S, Krystal AD, McCall WV, Schaefer K, Wilson A, Claus R, Rubens R, Roth T. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. Sleep. 2010 Feb 1;33(2):225-34.

Responsible Party:	Executive Medical Director, Clinical Research, Sepracor Inc.
ClinicalTrials.gov Identifier:	NCT00386334 History of Changes
Other Study ID Numbers:	190-904
Study First Received:	October 9, 2006
Results First Received:	February 13, 2009
Last Updated:	November 2, 2010
Health Authority:	United States: Food and Drug Administration