Objective: To invesigate the clinical thertapeutic effect

adverse effects and safety of Jieyu Pills in treatment of insomnia. Methods: 53 cases of insomnia were randomly divided into treatment group （n=31） treated by Jieyu Fills and control group （n= 22）treated by Trazodone. The therapeutic effects were assessed before administration and at the 14th and 28th days after administration with Sleeping Questionnaire （SQ）

Self-Rating Depression Scale （SDS）and Self-Rating Anxiety Scale（SAS）

and the adverse effect and the efficacy index were evaluated by the method in the scale of Clinical Global Impression （CGI）. Results: The marked improvement rate was 54. 9%. in the treatment group and 59. 1% in the control group. with no significant difference between the two groups （P>0. 05）. After treatment

the scores for SQ

SIXS and SAS decreased significantly as compared with those before treatment （P<0. 01 ）with no significant difference between the two groups （P>0. 05）. and the score in the treatment group was lower than that in the control group （P<0. 01） and the efficacy index in the treatment group was higher than that in the control group （P<0. 01）. Conclusion: Jieyu Pills and Trazodone have similar therapeutic effect on insomnia. but Jieyu Pills have less adverse effects.