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



Status:Completed
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:65 - 85
Updated:4/21/2016
Start Date:October 2006
End Date:February 2008

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

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.

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.

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.
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