Comparative study of lormetazepam and flurazepam in the treatment of insomnia.

Lormetazepam (1 and 2 mg) was tested against flurazepam (30 mg) and placebo in 60 patients (15 per treatment group) with initial, intermediate, or late insomnia. Patients were randomly assigned to treatment groups, and a double-blind protocol was followed. The four-week study included one week of use of the placebo, followed by two weeks of treatment with the active drug (in three groups) or continued use of the placebo (one group), and one week of use of the placebo (all four groups). Results showed that the active drugs were efficient in controlling insomnia. In some subjective parameters, only 2 mg of lormetazepam was significantly better than placebo. Tolerability of the drugs was considered good, with no interruption of treatment required because of adverse reactions. There was a rebound effect in one patient receiving 1 mg of lormetazepam and in three patients receiving flurazepam.