Objective：A meta-analysis was conducted to compare the clinical efficacy of Xiaoyaosan and Western medicine in the treatment of insomnia. Methods：The databases included CNKI，WanFang，VIP，CBM，Pubmed，Embase，Web of Science and Cochrane Library，et al. The quality evaluation was conducted for eligible clinical randomized controlled trials literature which meet inclusion and exclusion criteria. The effective rate，adverse reaction rate and Pittsburgh sleep quality index（PSQI） of related studies were analyzed by Revman 5.3 and Stata 16.0. Results：A total of 540 literature studies were screened，and 10 of them （including 693 patients） were finally selected. According to meta-analysis，compared with the west medicine group，the Xiaoyaosan group has a higher effective rate （RR=1.27，95%CI（1.16，1.38），P<0.00001） ，a lower clinical adverse reaction rate （RR=0.38，95%CI（0.21，0.70），P=0.002） and a more significant decrease in the PSQI （MD=1.43，95%CI（0.13，2.72），P=0.03）. Conclusion：Compared with conventional western medicine，the efficacy and the safety of insomnia treatment as well as the sleep quality of insomnia patients are significantly improved by Xiaoyaosan. However，due to the low quality of the included randomized controlled trials，a large number of scientifically reasonable clinical studies are urgently needed for further verification.