Table 1:

Randomized controlled trials of non-benzodiazepine sedative-hypnotic drugs versus benzodiazepines for the treatment of insomnia

StudyDrug, doseStudy duration, dNo. of patientsMean age, yrOutcomes
Non-benzodiazepineBenzodiazepine or placebo
Venter et al.14Zopiclone 7.5–15 mgTriazolam 0.25–0.5 mg174176.8
  • The zopiclone group woke up once on average and the triazolam group woke up nearly twice on average (mean 1.7; p = 0.06)

  • Adverse events reported in 35% of zopiclone and 38% of triazolam patients; difference not significant

Mouret et al.15Zopiclone 7.5 mgTriazolam 0.25 mg151065
  • Subjective aspects of sleep did not differ between groups

  • Sleep recordings did not differ between groups

Leppik et al.16Zolpidem 5 mgTriazolam 0.125 mg, or temazepam 15 mg, or placebo2833569
  • Subjective sleep latency with zolpidem decreased significantly from baseline by 32.7 to 39.7 min per night for weeks 1 through 4; difference was significant compared with placebo for a given week (p < 0.05)

  • Subjective sleep latency with temazepam decreased significantly from baseline by 30–39.4 min per night for weeks 1 through 4; difference was not significant compared with placebo at any time

  • Subjective sleep latency did not differ significantly between zolpidem and temazepam groups

  • Duration of subjective sleep did not change in any of the treatment groups compared with placebo

Roger et al.17Zolpidem 5 or 10 mgTriazolam 0.25 mg2120581
  • Questionnaire results, subjective sleep quality, and number of awakenings at night and in early morning improved in both groups (p < 0.01)

  • Proportion of patients who fell asleep in less than 30 min increased from 20% to 65% in both groups based on questionnaire responses (p < 0.001)

  • The increase in mean total sleep time was 1.5 h in the 5-mg zolpidem group v. about 2 h in the 10-mg zolpidem group and the triazolam group (p < 0.001)