Euhypnos® Forte (Temazepam) for Resistant Insomnia: Post-Marketing Surveillance, an Interim Report

Abstract

An interim report at six months of a post-marketing surveillance study of Euhypnos Forte, a new high-dose temazepam preparation for the treatment of insomniac patients resistant to conventional hypnotic dosage. The analysis includes 2,043 First Reports (FRs) of two weeks treatment and 669 Second Reports (SRs) of three months treatment. More than 95% of the patients took a nightly dose of two capsules, temazepam 40 mg. Adverse reactions were generally acceptable, consisting mainly of headache, vivid dreams, gastro-intestinal disturbances and hangover effects. The preparation was effective in 88.6% of patients at two weeks and 95.8% at three months. All patients had previously found other hypnotics ineffective. Euhypnos Forte was rated effective by 85.5% of the 874 patients who had previously found nitrazepam unsatisfactory, and by 90.0% of the 201 who found barbiturates unsatisfactory.