title: Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the long-term (8 months) efficacy of zolpidem in adults with chronic primary insomnia using polysomnography.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled clinical trial.
  
  
  METHODS
  Sleep disorders and research center.
  
  
  METHODS
  Healthy participants (n = 91), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia.
  
  
  METHODS
  Nightly zolpidem, 10 mg (5 mg for patients > 60 yrs) or placebo 30 minutes before bedtime for 8 months.
  
  
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525.
authors.affiliation: Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI 48202, USA. srandal1@hfhs.org
authors.forename: Surilla
authors.initials: S
authors.lastname: Randall
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Roehrs
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D017286:Polysomnography / Q000379:methods; D011446:Prospective Studies; D011725:Pyridines / Q000627:therapeutic use*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult; D000077334:Zolpidem
chemical_list: D006993:Hypnotics and Sedatives; D010919:Placebos; D011725:Pyridines; D000077334:Zolpidem
keywords: Primary insomnia; hypnotics; randomized controlled trial; zolpidem