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, nightlyzolpidem 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.
RCT Entities:
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.
Authors: T Hori; Y Sugita; E Koga; S Shirakawa; K Inoue; S Uchida; H Kuwahara; M Kousaka; T Kobayashi; Y Tsuji; M Terashima; K Fukuda; N Fukuda Journal: Psychiatry Clin Neurosci Date: 2001-06 Impact factor: 5.188
Authors: James K Walsh; Andrew D Krystal; David A Amato; Robert Rubens; Judy Caron; Thomas C Wessel; Kendyl Schaefer; James Roach; Gene Wallenstein; Thomas Roth Journal: Sleep Date: 2007-08 Impact factor: 5.849
Authors: Wallace B Mendelson; Thomas Roth; James Cassella; Timothy Roehrs; James K Walsh; James H Woods; Daniel J Buysse; Roger E Meyer Journal: Sleep Med Rev Date: 2004-02 Impact factor: 11.609
Authors: Evan S Herrmann; Ziva D Cooper; Gillinder Bedi; Divya Ramesh; Stephanie C Reed; Sandra D Comer; Richard W Foltin; Margaret Haney Journal: Psychopharmacology (Berl) Date: 2016-04-16 Impact factor: 4.530