RESUMO
BACKGROUND: Benzodiazepine-hypnotics are frequently used for treating insomnia in older adults; however, there is little information about adverse effects associated with their usage over several weeks, particularly in this segment of the population. OBJECTIVE: This study reports on the incidence of adverse effects of temazepam in older adults with chronic insomnia and examines whether the addition of cognitive-behaviour therapy (CBT) is associated with less drug used and fewer adverse effects. METHOD: Sixty patients with chronic and primary insomnia were randomized to temazepam (n = 20), placebo (n = 20) or temazepam plus CBT (n = 20). Data from the physicians' weekly assessments and patients' sleep diaries were used to evaluate adverse effects, the dose (7.5-30 mg) at which they occurred, and drug use patterns over the 8-week course of treatment. RESULTS: The incidence of adverse effects was infrequent, as shown by the low percentages of complaints reported by patients in the temazepam (7.8%), placebo (10.8%) and combination groups (8.3%). The severity of adverse events was mild and decreased over the course of treatment. The maximum dose was reached by 10 patients receiving temazepam, 14 placebo and 7 in the combined treatment. The average nightly dosage used was 20 mg for both the temazepam and placebo groups and 16 mg for the combined condition. Patients receiving temazepam plus CBT used less drugs, with approximately the same incidence of adverse effects. CONCLUSION: Temazepam is a safe hypnotic for use by older adults over an 8-week treatment period. There are few adverse effects and behavioural tolerance to those effects develop over time. The addition of cognitive-behavioural intervention reduced both the amount of medication used and the incidence of adverse effects, with comparable sleep improvements.