Objective To evaluate the therapeutic effect and safety of Xia’s Sleep No.1 for insomnia of deficiency pattern.Methods Totally 120 cases of insomnia according to Chinese Classification of Mental Disorders Version 3 （CCMD-3） criteria with deficiency syndrome were randomly divided into two groups.Xia’s Sleep No.1 was given to 60 patients in the treatment group

while 1mg of Estazolam was taken in the control group.The treatment course lasted for 6 weeks.Clinical effect was evulated by Athens Insomnia Scale （AIS） and pathogenetic condition

while adverse effect by Treatment Emergent Symptom Scale （TESS）.Results The total effective rate of the treatment group （80%） was higher than that of the control group （70%）;but there was no significant difference between both groups （P>0.05）.The effective rate on long-term insomnia of the treatment and control group was 77.8% and 52.4% respectively;and there was significant difference between both groups （P<0.05）.The adverse effect in the treatment group was fewer and slighter than that in the control group.Conclusion Xia’s Sleep No.1 is effective and safe to insomnia of deficiency pattern.