To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.
An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 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
420
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
The change from baseline in subjective sleep latency averaged over the double-blind treatment period.
Time frame: 8 weeks
Change from baseline in subjective total sleep time averaged over the double blind treatment period.
Time frame: 8 weeks
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Birmingham, Alabama, United States
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Mesa, Arizona, United States
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Scottsdale, Arizona, United States
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Irvine, California, United States
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La Mesa, California, United States
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National City, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Redlands, California, United States
...and 54 more locations