Evaluation of efficacy and safety of midazolam administered orally in sleep disorders. A dose-finding study.

Efficacy (sleep--sedation) and tolerance of 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine (midazolam, Ro 21-3981, Dormicum) in a dosage of 10 mg to 30 mg p.o. were evaluated in a multi-center pilot study in 75 hospitalized patients, with an age range of 20 to 80 years. The patients suffered from mild to moderate insomnia, secondary to musculoskeletal disorders, peripheral nerve diseases and allergies. The optimal dose range was established on the basis of the relation between the degree of insomnia, age of the patients and the dose needed to obtain the optimal results for the sleep parameters. By this method it could be found that 10 mg was the optimal dose for patients over 60 years with mild to moderate insomnia; for patients less than 60 years old with moderate insomnia 15 mg to 20 mg midazolam was the optimal dose, and for patients with mild insomnia 10 mg was sufficient.