RESUMO
Objective To observe the efficacy and safety of Shenqiwuweizikeli for treating chronic insomnia.Methods One hundred and ninety-six cases of subjects were randomly divided into Shenqiwuweizikeli group (n =98) and Estazolam tablets group (n =98).The pittsburg sleep quality index (PSQI) was adopted to evaluate the clinical effects and records of adverse reactions during the study period.Also the lab routine inspection(blood routine,urine routine,liver and kidney function, electrocardiogram were conducted to evaluate safety.Results The Shenqiwuweizikeli and Estazolam tablets all had significant effects for chronic insomnia.The total effective rate of Shenqiwuweizikeli group was 92.86％ (91/98), of Estazolam tablets group was 93.88％(92/98) ,and there was no significant difference (P＞0.05).There were no abnormalities in terms of each routine inspection index.After stopping take the medicine, The adverse reactions including bounce sex insomnia(60 cases), daytime sleepiness/drowsiness (55 cases), dizziness with lacking of power and light headedness(23 cases) in Estazolam tablets group were all more than Shenqiwuweizikeli group with significant difference(P＜0.01).Conclusion The Shenqiwuweizikeli has definite efficacy and safety for treated with chronic insomnia without withdrawal of recoil and dependence.