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Efficacy and Safety of Zolpidem Extended Release in Elderly Primary Insomnia Patients

From the Sleep Medicine and Research Center, St. John’s Mercy and St. Luke’s Hospitals, St. Louis, MO (JKW); the Department of Psychology, Saint Louis University, St. Louis, MO (JKW); Clinical Development, Sanofi-Aventis Research, Chilly Mazarin, France (CS); and the Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI (TR).

Objectives: To evaluate the clinical efficacy and safety of zolpidem extended release for the treatment of primary insomnia in elderly patients.

Methods: A randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted. A total of 205 (117 women, 88 men; mean age 70.2 ± 4.5 years) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition–defined primary insomnia patients were randomized to 3 weeks of nightly treatment with either zolpidem extended release 6.25 mg or placebo; 198 patients completed the study.

Results: Relative to placebo, zolpidem extended release 6.25 mg significantly decreased wake time after sleep onset during the first six hours of the night, as measured by polysomnogram (PSG). PSG latency to persistent sleep was reduced and PSG total sleep time was increased, both at nights 1/2 and 15/16. Patient self-report measures were significantly better with zolpidem extended-release 6.25 mg than with placebo throughout treatment. Some PSG measures indicated a worsening of sleep for a single night after abrupt discontinuation of zolpidem extended release. No next-morning residual effects were observed. The overall incidence and nature of adverse events was comparable between the two groups.

Conclusions: Zolpidem extended release 6.25 mg improved both sleep maintenance and sleep induction in elderly primary insomnia patients during three weeks of administration.

Key Words: Primary insomnia • extended-release zolpidem • hypnotic medication • elderly

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