Objective:To observe the clinical effect of Shumian capsules for insomnia.Methods:A total of 86 cases of patients with insomnia were randomly divided into the control group and the observation group,43 cases in each group.The control group was treated with estazolam,and the observation group was treated with Shumian capsules.Both groups were treated for four weeks.The clinical effect and the adverse reactions in the two groups were observed and compared.The quality of sleep was evaluated by scores of Pittsburgh Sleep Quality Index(PSQI).Results:The total effective rate was 97.67% in the observation group and 83.73% in the control group,the difference being significant(P<0.05).After treatment,the scores of PSQI in the two groups were significantly decreased when compared with those before treatment(P<0.05),and the score in the observation group was significantly lower than that in the control group(P<0.05).The incidence of adverse reactions was 4.65% in the treatment group and 13.95% in the control group,the difference being significant(P<0.05).Conclusion:Shumian capsule has definite curative effect on insomnia,and can significantly improve the quality of sleep with good medication safety,which is worthy of clinical promotion and application.