A double-blind comparison of two lormetazepam doses in elderly insomniacs

Summary

The relative efficacy and tolerability of two lormetazepam doses, 0.5 mg and 1.0 mg, were compared in 145 elderly insomniacs in a double-blind, multi-centre study. On entry, data were recorded on the patient characteristics and sleep pattern, and patients were allocated at random to receive treatment with either 0.5 mg or 1.0 lormetazepam per night for 7 nights. Details were recorded daily in a diary by patients on sleep latency, the number of night-time awakenings, time of morning awakening, and whether they awoke refreshed. A record was also kept of any adverse effects of treatment. At the end of the study period, an overall assessment was made by the physician of the patients' response to treatment. The results showed that patients in both dose groups improved significantly (p = 0.001) in the three principal efficacy measures, but there were no apparant trends in the time when patients awakened in the morning. The only evidence of a difference in response to the two doses was that significantly (p < 0.01) more patients on the larger dose were given a global rating of ‘much improved’ by the physician. Five patients withdrew from the study; 2 because of lack of efficacy, 2 because of side-effects, and 1 because of a suspected myocardial infarction not related to therapy. Only 6% of patients (4 on each dosage) reported adverse effects, most frequently related to carry-over sedation, i.e. drowsiness, sleepiness, muzzy head. Both doses of lormetazepam, therefore, were well tolerated and effective in elderly insomniacs and there is no basis for recommending the higher dose; it is acceptable if required, however, to ensure maximum benefit.

Key Words::

• Lormetazepam
• insomnia
• dose-response relationship
• drug elderly