Euhypnos® Forte, High Dose Temazepam for Resistant Insomnia: Post-Marketing Surveillance in 10,057 Patients Unresponsive to Conventional Hypnotic Dosage

Abstract

A post-marketing surveillance study of Euhypnos® Forte (temazepam 20 mg) capsules for the treatment of insomnia in 10,057 patients previously unresponsive to other hypnotics given in conventional doses. Patients were prescribed a nightly dose of 40 or 60 mg, but 95% actually took 40 mg. At 2 weeks, 89% of patients found the treatment effective, as did 95% at 3 months. Hangover, severe enough to stop treatment, occurred in less than 3% of patients, and other adverse reactions such as headache, dreams, gastro-intestinal disturbance and hangover symptoms were reported by only 6% of patients at 2 weeks and 4% at 3 months. The most common reason for stopping treatment was the patient having no further need of hypnotics. Euhypnos Forte was effective in 88% of 3,800 patients who had found nitrazepam unsatisfactory and 90% of 1,013 patients unresponsive to barbiturates.