Evaluation of the efficacy and tolerance of orally administered midazolam as hypnotic agent compared with oxazepam in the treatment of insomnia of mild to moderate severity.

In a double-blind parallel study performed in 40 hospitalized patients, suffering from mild to moderate insomnia, the efficacy and tolerance of 15 mg of 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine (midazolam, Ro 21-3981, Dormicum) administered p.o. were compared with those of 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one (oxazepam) in the same dosage. The results show comparable values for the two drugs but with significantly better results for midazolam in the parameters: time taken to fall asleep and number of nocturnal awakenings.

RCT Entities:   Population Interventions Outcomes