To evaluate the long-term (8 months) efficacy of zolpidem in adults with chronic primary insomnia using polysomnography.
Randomized, double-blind, placebo-controlled clinical trial.
Sleep disorders and research center.
Healthy participants (n = 91), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia.
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.
In adults with primary insomnia, nightly zolpidem administration remained efficacious across 8 months of nightly use.
Randall S; Roehrs TA; Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. SLEEP 2012;35(11):1551-1557.