Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2012 Nov 1;35(11):1551-7.
doi: 10.5665/sleep.2208.

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

Surilla Randall  1 , Timothy A Roehrs, Thomas Roth
Affiliations
Randomized Controlled Trial

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

Surilla Randall et al. Sleep. .

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.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Participant disposition diagram over the 8-month clinical trial.
See this image and copyright information in PMC

References

    1. Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7–S10. - PMC - PubMed
    1. Sateia MJ, Doghramji K, Hauri PJ, Morin CM. Evaluation of chronic insomnia. Sleep. 2000;23:1–66. - PubMed
    1. Sleep; National Institutes of Health State of the Science Conference Statement on Manifestations and Management of Chronic Insomnia in Adults; June 13-15, 2005; 2005. pp. 1049–57. - PubMed
    1. Krakow B, Ulibarri VA, Romero EA. Patients with treatment-resistant insomnia taking nightly prescription medication for sleep: a retrospective assessment of diagnostic and treatment variables. Prim Care Companion J Clin Psychiatry. 2010;12:e1–e10. - PMC - PubMed
    1. Krakow B, Ulibarri VA, Romero EA. Persistent insomnia in chronic hypnotic users presenting to a sleep medical center: retrospective chart review of 137 consecutive patients. J Nerv Ment Dis. 2010;198:734–41. - PubMed

Publication types

Associated data