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

Sumitomo Pharma

Status and phase: Completed; Phase 4

Conditions: Insomnia

Treatments: Drug: Placebo; Drug: Eszopiclone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386334

190-904

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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388 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Week -2 to day 0 single blind one tablet placebo in the evening. Double blind period: Day 1 to Week 12 double blind one tablet placebo in the evening. Follow up period: two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.

Treatment:

Drug: Placebo

Eszopiclone

Experimental group

Description:

Week -2 to day 0 single blind one tablet placebo in evening. Double Blind period: Day 1 to Week 12 double blind one tablet 2 mg of eszopiclone in evening. Follow up period consists of two weeks (Weeks 13-14) single blind one tablet placebo in evening, and two weeks (Weeks 15-16) no drug washout.

Treatment:

Drug: Eszopiclone

Drug: Placebo