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Sleep. 2012 Nov 1;35(11):1551-7. doi: 10.5665/sleep.2208.

Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study.

Author information

1
Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI 48202, USA. srandal1@hfhs.org

Abstract

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.

KEYWORDS:

Primary insomnia; hypnotics; randomized controlled trial; zolpidem

PMID:
23115404
PMCID:
PMC3466802
DOI:
10.5665/sleep.2208
[Indexed for MEDLINE]
Free PMC Article
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