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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Eszopiclone

Criteria

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.