Age-specific doses of lormetazepam as a night sedative in cases of chronic sleep disturbance.

Abstract

Lormetazepam, a new benzodiazepine derivative, was tested under double blind conditions in order to find the optimal dosage for different age groups of out-patients. 120 patients suffering from chronic sleep disturbance were included in the study: a younger group (age 20 to 55) and an older group (age 56 to 85 years). Four different doses were given to each age group: 0.5, 1.0, 2.0, and 3.0 mg to the younger group and 0.5, 1.0, 1.5, and 2.0 mg to the older group. A pre-placebo week (i.e. when all patients received placebo) in which baseline data were recorded preceded the two verum weeks, and these were followed by a post-placebo or withdrawal week (again all patients receiving placebo). The level of significance accepted for statistical decisions was alpha = 0.05. No differences in effects between the different doses were observed with regard to sleep pattern variables (sleep latency, sleep duration, frequency of awakenings, sleep quality, occurrence of 'bad' dreams) with the exception of sleep quality which was better in the older group than in the younger group after 0.5 mg in week 2. Considerable differences with regard to hangover feelings the next morning and during the next day (morning feelings, tranquility, alertness, and concentration), comparison of the effects of discontinuing therapy upon the above-mentioned sleep pattern variables and small differences in side effects--which were few--led to the following conclusion: --0.5 mg stood out as the best dose for the older group. --None of the dosages given to the younger group emerged clearly as superior. However, it would seem that the 1 mg dose should be the dose recommended, since fewer unfavourable scores and side effects appeared after this dose.