Comparative clinical studies with midazolam, oxazepam and placebo.
The efficacy and safety of midazolam compared with oxazepam and placebo were investigated in 50 hospital patients (19 males, 31 females; age range 21 to 74 years) in a double-blind parallel group study. On the first 2 nights (selection phase), patients received only placebo. On the next 5 nights, they received either 15 mg midazolam, 15 mg oxazepam or placebo. They received no medication on the last 2 nights and were kept under observation (withdrawal phase). Compared with placebo, both benzodiazepines shortened sleep onset latency, reduced the number of awakenings and improved sleep quality. All 3 compounds were well tolerated with only few, mild side-effects (headache, nausea) in the 2 verum groups. Psychometric performance was not impaired on the morning following drug administration. The overall patients' assessments showed 80% satisfaction with midazolam, 66% with oxazepam and 10% with placebo. Midazolam and oxazepam yielded similar results, although midazolam induced sleep more rapidly and was rated more favourably by the patients. Midazolam, in a dose of 15 mg, is thus an effective, fast-acting, well-tolerated hypnotic without residual effects and is suitable for the treatment of insomnia of mild to moderate degree. Oxazepam in a dose of 15 mg is also well suited for the treatment of sleep disorders, particularly if a rapid onset of action is not required.
D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004325:Dreams; D005260:Female; D006801:Humans; D008297:Male; D008874:Midazolam; D008875:Middle Aged; D010076:Oxazepam / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*
D014151:Anti-Anxiety Agents; D010919:Placebos; D001569:Benzodiazepines; D010076:Oxazepam; D008874:Midazolam