Comparative studies on the efficacy of brotizolam and nitrazepam: a multi‐centre study.

Abstract

1 Efficacy and tolerability of brotizolam (0.25 and 0.5 mg) were compared over a 6-day period with nitrazepam (5.0 mg) in middle-aged patients (less than 65 years) with sleep disturbances requiring medication. The study was double-blind and randomised with a cross-over design. 2 Each preparation reduced sleep onset latency and frequency of awakenings, and improved quality and duration of sleep as well as subjective condition on awakening. Brotizolam 0.25 mg was found to be equally effective as 0.5 mg, and so the lower dose is recommended for the middle aged.

Brotizolam and chronic insomnia: a multi‐centre study.

“…However, although there was no evidence of untoward effects with the highest dose (0.5 mg), the efficacy of the lower doses, together with other experimental (Nicholson et al, 1980;Roehrs et al, 1983) and clinical Lohmann et al, 1983) studies, would suggest the dose range 0.125-0.25 mg as appropriate in the treatment of insomnia. Further, brotizolam was found to be effective over a 4-week period of ingestion, and on withdrawal there was no evidence of an adverse effect on sleep which would suggest a rebound phenomenon.…”

“…After the 4week period of medication assessments of sleep tended to return to those of the control period.This study together with related investigations (Sinchez-Martfnez & Landa-Palos, 1982; Rodrfguez et al, 1981;Velasco et al, 1981) has demonstrated in a clinical setting the usefulness of brotizolam as an hypnotic, although it did not establish any consistent dose-related differences. However, although there was no evidence of untoward effects with the highest dose (0.5 mg), the efficacy of the lower doses, together with other experimental (Nicholson et al, 1980;Roehrs et al, 1983) and clinical Lohmann et al, 1983) studies, would suggest the dose range 0.125-0.25 mg as appropriate in the treatment of insomnia. Further, brotizolam was found to be effective over a 4-week period of ingestion, and on withdrawal there was no evidence of an adverse effect on sleep which would suggest a rebound phenomenon.413S…”