Use of zolpidem 10 mg as a benzodiazepine substitute in 84 patients with insomnia

The antagonistic effects of zolpidem 10 mg on withdrawal symptoms caused by abrupt or gradual discontinuation (half-dose over 4 nights) of triazolam 0 .25 mg in patients with chronic insomnia, who had been receiving regular tr eatment for over one month, were assessed in a randomized, double-blind, pl acebo-controlled clinical trial in general practice. Eighty-four patients w ere enrolled, mostly women (67.9%), with a mean age of 54.3 +/- 11.0 years. Twenty-one different general practitioners were solicitated for the recrui tment. The subjects were randomized into four groups, and all received tria zolam 0.25 mg during the run-in phase from day I (D1) to day 3 (D3). The fo llowing treatments were given from D4 to D7: triazolam 0.125 mg + zolpidem 10 mg (Group 1); zolpidem 10 mg (Group 2); placebo (Group 3); or triazolam 0.125 mg + placebo (Group 4). Groups 1 and 2 received zolpidem 10 mg from D 7 to D24, while Groups 3 and 3 received placebo. Finally, all four groups r eceived placebo (blind withdrawal phase) from D25 to D28. The following ass essment criteria were used: clinical global impression (CGI) scale complete d by the practitioner; patient questionnaire based on routine sleep criteri a, wakefulness and daytime alertness. Secondary criteria were sleep diaries and visual analogue scales. Study drop-outs were reported and explained. T he effectiveness/tolerance ratio was found to be statistically significant using the CGI (p < 0.007) in favour of zolpidem 10 mg. There was no signifi cant difference in patients subjective assessment between the groups except for nightmares (p < 0.04) less frequent in patients receiving zolpidem. Zo lpidem was found to be more effective than placebo at D21 (CGI) according t o sleep diaries; the zolpidem group showed a statistically significant diff erence as compared to the three other concerning four sleep parameters: num ber of awakenings, anxiety, sleep duration, energy. Drop-out rates were sig nificantly lower in the zolpidem group than in other ones (p < 0.01). Abrup t and gradual triazolam withdrawal over 4 nights induced withdrawal symptom s. Equally no specific phenomena were observed at the end of the trial duri ng the blind withdrawal phase. This study shows that zolpidem 10 mg improve s sleep quality and reduces withdrawal symptoms after abrupt or gradual dis continuation of triazolam 0.25 mg in chronic patients with chronic insomnia . (C) 1998 John Wiley & Sons, Ltd.