NCT00386334

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 388 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Eszopiclone	2 mg tablet once per day in the evening
DRUG	Placebo	Tablet one per day in the evening.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-10-11
• Last updated: 2016-03-14
• Results posted: 2009-06-02

Locations

82 sites across 1 country: United States