Efficacy of Eight Months of Nightly Zolpidem: A Prospective Placebo-Controlled Study

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.