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

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.

Timeline

Start

2006-10

Primary completion

2008-02

Completion

2008-02

Outcome

Met primary endpoint

registry MEAN Placebo: 33.18 (Standard Deviation 50.02) minutes MEAN Eszopiclone: 63.24 (Standard Deviation 52.76) minutes NCT00386334 ↗

registry analysis (superiority or other test); Placebo vs Eszopiclone; p <0.0001; ANCOVA; note: Multiple comparisons not applied due to only two treatments in the study. NCT00386334 ↗

Publications

• Results Ancoli-Israel S, Krystal AD, McCall WV, Schaefer K, Wilson A, Claus R, Rubens R, Roth T. A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia. Sleep. 2010 Feb;33(2):225-34. doi: 10.1093/sleep/33.2.225.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eszopiclone	Small molecule	2 mg	—

Indications