Second Reports Research Articles

Post-marketing surveillance of Euhypnos (temazepam): a new hypnotic.

A post-marketing surveillance study of Euhypnos (temazepam), a new short-acting benzodiazepine hypnotic. A total of 12,350 patients requiring a sleep inducer were treated for up to 3 months with doses of 10-30 mg at night. After 2 weeks 80% of First Reports (FRs) rated Euhypnos effective and at 3 months this had risen to 92% of 3062 Second Reports (SRs). Hangover was reported in 7% of FRs and 2% of SRs but in general the drug was well tolerated with adverse reactions consisting mainly of morning nausea, headache, drowsiness and vivid dreaming. Eighty-seven per cent of FRs and 93% of SRs were 'Clean' reporting no hangover, adverse reaction or event of any kind.

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

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.