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VOLUME 35, ISSUE 11

CONTROLLED STUDY OF THE EFFICACY OF EIGHT MONTHS OF NIGHTLY ZOLPIDEM
Efficacy of Eight Months of Nightly Zolpidem: A Prospective Placebo-Controlled Study

http://dx.doi.org/10.5665/sleep.2208

Surilla Randall, PhD; Timothy A. Roehrs, PhD; Thomas Roth, PhD

Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI



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Study Objectives:

To evaluate the long-term (8 months) efficacy of zolpidem in adults with chronic primary insomnia using polysomnography.

Design:

Randomized, double-blind, placebo-controlled clinical trial.

Setting:

Sleep disorders and research center.

Participants:

Healthy participants (n = 91), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia.

Interventions:

Nightly zolpidem, 10 mg (5 mg for patients > 60 yrs) or placebo 30 minutes before bedtime for 8 months.

Measurements and Results:

Polysomnographic sleep parameters and morning subject assessments of sleep on 2 nights in months 1 and 8. Relative to placebo, zolpidem significantly increased overall total sleep time and sleep efficiency, reduced sleep latency and wake after sleep onset when assessed at months 1 and 8. Overall, subjective evaluations of efficacy were not shown among treatment groups.

Conclusions:

In adults with primary insomnia, nightly zolpidem administration remained efficacious across 8 months of nightly use.

Clinical Trial Information:

ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525.

Citation:

Randall S; Roehrs TA; Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. SLEEP 2012;35(11):1551-1557.

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