To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of eszopiclone 3 mg in women with insomnia secondary to perimenopause or menopause. Eligible subjects will be randomized to either eszopiclone 3 mg or placebo nightly for four 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
410
eszopiclone 3 mg
placebo tablet
mean subjective SL
Time frame: Week 1
mean subjective WASO
Time frame: Week 1
Mean subjective SL
Time frame: Weeks 2, 3, 4
Mean subjective WASO
Time frame: Weeks 2, 3, 4
Mean subjective TST
Time frame: Weeks 1, 2, 3, 4
Mean number of awakenings
Time frame: Weeks 1, 2, 3, 4
Sleep quality and depth
Time frame: Weeks 1, 2, 3, and 4
Daytime alertness
Time frame: Weeks 1, 2, 3, and 4
Ability to concentrate
Time frame: Weeks 1, 2, 3, and 4
Physical well-being
Time frame: Weeks 1, 2, 3, and 4
Ability to function
Time frame: Weeks 1, 2, 3, and 4
Mean subjective number of nocturnal awakenings due to hot flashes
Time frame: Weeks 1, 2, 3, and 4
Mean number of hot flashes per day
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Unnamed facility
Mobile, Alabama, United States
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San Diego, California, United States
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Denver, Colorado, United States
Unnamed facility
Newington, Connecticut, United States
Unnamed facility
Aventura, Florida, United States
Unnamed facility
Clearwater, Florida, United States
Unnamed facility
Fort Meyers, Florida, United States
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Gainesville, Florida, United States
Unnamed facility
Melbourne, Florida, United States
Unnamed facility
Miami, Florida, United States
...and 41 more locations
Time frame: Weeks 1, 2, 3, and 4
Mean number of nocturnal hot flashes per night
Time frame: Weeks 1, 2, 3, and 4
Mean severity of hot flashes
Time frame: Weeks 1, 2, 3, and 4
ESS score
Time frame: Weeks 2 and 4
ISI score
Time frame: Weeks 2 and 4
GCS score
Time frame: Weeks 2 and 4
SDS score
Time frame: Week 4
MenQOL score
Time frame: Week 4
MADRS score
Time frame: Week 4
Physician Global Assessment
Time frame: Week 4
withdrawal effects will be assessed for the ISI, ESS, MADRS, MenQOL, Greene Climacteric Scale, Sheehan Disability Scale, and Physician Global Assessment.
Time frame: Week 5