The efficacy and safety of brotizolam for the treatment of insomnia: a randomly blinded controlled trial

Objective:To evaluate the efficacy and safety of brotizolam for the treatment of insomnia in China. Method:The study was designed as a random,double blind,double simulated research,controlled with active medicine and treated with flexible dose. Totally 32 patients with insomnia were recruited according to Chinese classification and diagnostic criteria of mental disorders third edition and were evenly divided into two group ( 16 patients in brotizolam group and 16 patients in estazolam group) . The whole treatment course lasted 2 weeks followed with 1 week administration of placebo. The sleep disorder rating scale ( SDRS) was used to evaluate the efficacy at baseline,the end of 1st week,2nd and 3rd week after treatment. The side effect of the drug was evaluated for safety. Results:At the end of 2nd week after treatment,SDRS scores of both groups decreased significantly( P 0. 01) but there was no statistical difference between groups ( P 0. 05) . At the end of 1st week,both two group showed effective rate of 62. 5% ( χ2 = 0,df = 1,P 0. 05) ; at the end of 2nd week, estazolam group showed effective rate of 68. 8% ,while brotizolam group showed an effective rate of 87. 5% ( χ2 = 1. 65,df = 1,P 0. 05) ; at the end of 3rd week,estazolam group showed effective rate of 43. 8% ,while brotizolam group showed an effective rate of 37. 5% ( χ2 = 1. 13,P 0. 05 ) ,the effective rates were no significant difference between brotizolam group and estazolam group at each point of time. Two patients ( 12. 5% ) in brotizolam group had the adverse effects while four patients ( 25. 0% ) in control group had adverse effects. Conclusion:Brotizolam is an effective and safe drug for the treatment of insomnia,which is similar to estazolam.