Randomized, double blind trial of Zolpidem 10 mg versus triazolam 0.25 mg for treatment of insomnia in general practice

Abstract

Objective — To compare the efficacy of two short acting hypnotics, the benzodiazepine triazolam and the imidazopyridine Zolpidem, for treatment of insomnia in general practice.

Design — Randomized double-blind study. Patients were given triazolam 0.25 mg or Zolpidem 10 mg for 14 days.

Setting — Multi-practice comprising 40 general practitioners.

Subjects — 178 patients suffering from insomnia were included in the study, data from 139 patients were used in the analyses.

Results — We found no statistically significant differences between the two groups regarding sleeping time, number of awakenings, or sleep quality (VAS). Morning feeling (VAS) and day feeling (VAS) were numerically better for Zolpidem, although not statistically significant. There was no statistically significant difference in the number of patients experiencing side effects in the two treatment groups. Conclusion — On a short-term basis administration of Zolpidem (10 mg) appeared as effective and well tolerated as triazolam (0.25 mg) — and thus Zolpidem constitutes a suitable alternative for the treatment of insomnia in general practice.

Main outcome measures — Sleep quality was recorded in the morning (duration of sleep in hours, number of awakenings, and sleep quality on a visual analogue scale (VAS)), and day quality was recorded in the evening (tired/rested, unalert/alert, tired/fresh, all on VAS-scales) during the 14 days' treatment period.

Key Words:

• Zolpidem
• imidazopyridines
• triazolam
• benzodiazepines
• sleep
• insomnia
• general practice