HYPNOTIC EFFECTS OF LOW-DOSES OF QUAZEPAM IN OLDER INSOMNIACS

To evaluate the efficacy and safety of reduced doses of the benzodiaze pine agonist quazepam in older insomniacs, 30 men and women >60 years old with chronic insomnia were randomly assigned to receive 0, 7.5, or 15 mg quazepam. After two placebo nights, each subject received the a ppropriate dose for seven consecutive nights, which was followed by tw o placebo recovery nights. Both doses increased total sleep time relat ive to placebo during the early (nights 1 and 2) and late (nights 6 an d 7) treatment phases. The low dose reduced sleep latency during the l ate phase, whereas the high dose reduced sleep latency in both early a nd late treatment phases. These observed hypnotic effects for both dos es did not diminish over the seven nights of repeated administration. There also was a continued hypnotic effect during the two nights of pl acebo recovery for both doses. Analyses of plasma concentrations of qu azepam and its metabolites suggested the continued drug effects on sle ep during recovery are due to the metabolite desalkylflurazepam. In th e safety evaluation done by means of adverse drug event assessments an d postsleep questionnaires, the adverse events reported were minimal a nd not drug or dose related.