title: Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle-of-the-night awakening in insomnia.
abstract: OBJECTIVE
  Evaluate potential gender effects on efficacy and safety of a buffered zolpidem sublingual tablet (ZST) formulation.
  
  
  METHODS
  Post hoc analysis of the pivotal sleep laboratory and outpatient studies, per gender.
  
  
  RESULTS
  In the sleep laboratory study, polysomnography-derived latency to persistent sleep after middle-of-the-night was significantly improved for both genders at both 1.75 mg and 3.5 mg ZST (females: 15.7 and 8.6 min, respectively, vs. 27.7 min [placebo]; males: 19.0 and 12.7 min vs. 29.0 min [placebo]) with no significant gender differences. In the outpatient study, subjective sleep onset latency after middle-of-the-night was significantly shorter for both genders treated with ZST 3.5 mg versus placebo over the 4-week average (females: 37.3 vs. 59.4 min, p < 0.0001; males: 38.6 vs. 55.1 min, p ≤ 0.01). There were no gender differences in subjective sleep onset latency after middle-of-the-night awakening. In the outpatient study, weekly usage of ZST and placebo by both genders declined throughout the study. Morning alertness following dosing nights improved in both genders, although significant only in females. In both studies, there were no gender differences in adverse events.
  
  
  CONCLUSIONS
  Time to return to sleep after middle-of-the-night dosing with ZST improved in both genders, with no gender differences in efficacy and safety.
authors.affiliation: Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, Minnesota, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
authors.forename: Frank
authors.initials: F
authors.lastname: Steinberg
authors.forename: Nikhilesh N
authors.initials: NN
authors.lastname: Singh
authors.forename: Margaret
authors.initials: M
authors.lastname: Moline
mesh_terms: D000286:Administration, Sublingual; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010045:Outpatients; D017286:Polysomnography; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012737:Sex Factors; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014851:Wakefulness; D000077334:Zolpidem
chemical_list: D006993:Hypnotics and Sedatives; D011725:Pyridines; D000077334:Zolpidem
keywords: efficacy; gender; insomnia; middle-of-the-night awakening; safety; sublingual zolpidem tartrate