Objective:To evaluate the clinical efficacy and safety of Anmeidan in the treatment of adult chronic insomnia.Methods:This study was designed as a multicenter,randomized,double-blind,placebo-controlled trial.A total of 480 chronic insomnia patients treated in 4 hospitals in Hubei,Guangdong and Gansu from November 2020 to September 2021 were divided into treatment group and control group at 1∶1 ratio.The treatment group was given Anmeidan granules and the control group was given Anmeidan granules simulant.The treatment course was 4 weeks.Pittsburgh sleep quality index(PSQI)scores,parameters of non-rapid eye movement sleep 1(N1),N2,N3,rapid eye movement sleep(REM),total sleep time(TST),sleep efficiency(SE),awakening time(AT),sleep latency(SL)and safety indexes in polysomnography(PSG)were compared between the two groups before and after treatment.Results:The total effective rate of treatment group and control group were 69.0％(147/213)and 37.1％(75/202),respectively.The therapeutic effect of treatment group was better than that of control group(P＜0.01).Compared with before treatment,TST was significantly prolonged,SE was significantly increased,AT was significantly shortened and the proportion of N2 stage was significantly increased in treatment group after treatment(P＜0.01),and the proportion of N1 stage was decreased(P＜0.05),while AT was only shortened in control group after treatment(P＜0.05).There was no significant difference in the proportion of adverse events between the treatment group and the control group.Conclusion:Anmeidan is effective and safe in treating adult chronic insomnia.
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