The clinical and psychometric evaluation of a new hypnotic drug, loprazolam, in general practice.
A double-blind crossover study was carried out in 16 patients with insomnia to assess the effectiveness and tolerance of a new hypnotic, loprazolam, with that of nitrazepam and placebo. Patients received 1 capsule each night for 7 days of either 1 mg loprazolam, 5 mg nitrazepam or placebo and then 7 days' treatment with each of the other medications in random order. The results of analogue rating scale assessment by the patients showed that 'ease of getting to sleep' and 'quality of sleep' were significantly better with loprazolam than with placebo. Loprazolam appeared to be at least as effective, if not more so, than nitrazepam. There were no significant differences between treatments on the morning muzziness assessment, which was low in each group, or in the psychometric tests carried out indicating that loprazolam is unlikely to produce hangover effects. There were no obvious differences between treatments in the incidence or frequency of side-effects spontaneously volunteered by the patients.
D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents; D001569:Benzodiazepines; D001570:Benzodiazepinones / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009567:Nitrazepam / Q000627:therapeutic use; D011597:Psychomotor Performance / Q000187:drug effects*; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*
D014151:Anti-Anxiety Agents; D001570:Benzodiazepinones; D006993:Hypnotics and Sedatives; D001569:Benzodiazepines; C020168:triazulenone; D009567:Nitrazepam