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Published on: February 17, 2023
Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study
Surilla Randall1, Timothy A Roehrs, Thomas Roth
1Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI 48202, USA. srandal1@hfhs.org
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.
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