Objective:To investigate the effects and safety of catgut embedding on alleviating insomnia.Methods:Totally 510 patients with insomnia were divided into 5 Chinese medicine (CM) syndrome types:Xin (Heart) and Pi (Spleen) deficiency,yin deficiency with excess fire,Xin and gut qi deficiency,Wei (Stomach) disorder,and qi and blood deficiency,respectively.These 5 types of patients were randomly assigned to a catgut embedding group,an acupuncture group or a medication group (30 cases in Xin and Pi deficiency type,Wei disorder type,Xin and gut qi deficiency type,respectively;40 cases in yin deficiency with excess fire type and qi and blood deficiency type,respectively).In the catgut embedding group,patients were treated by implanting catgut into acupoints once every 10 days for a total of 30 days.In the acupuncture group,patients were treated with acupuncture once per day over 30 days (excluding weekends);and patients in the medication group took 1 mg Eurodin Tablet orally every night for 30 days.Pittsburgh Sleep Quality Index (PSQI) was evaluated before treatment,on 30 and 60 days after the first treatment,respectively.The International Unified Sleep Efficiency Value (IUSEV) was measured at 30 and 60 days.The safety was evaluated after treatment and adverse events were analyzed.Results:The objective PSQI scores including subjective sleep quality,sleep latency,sleep duration,habitual sleep efficiency,sleep disturbance,daytime dysfunction,and total scores at 30 days were significantly improved compared with pre-treatment in the catgut embedding and acupuncture groups (P＜0.01 or P＜0.05).At 30 days,the PSQI scores in catgut embedding group were superior to the medication group in the patients with each type of insomnia,with the exception of sleep duration (P＜0.01 or P＜0.05).At 60 days,significant differences were found between the catgut embedding group and the medication group (P＜0.01 for all indices).The IUSEV scores in the catgut embedding group were significantly higher than the acupuncture group at 60 days,and the scores in acupuncture group were higher than the medication group at 30 days (P＜0.05 for all types).No severe adverse events were found in this study.Conclusions:Acupoint catgut embedding and acupuncture were more effective than medication in alleviating insomnia syndrome in different Chinese medicine syndrome type.However,the sustained effects of acupoint catgut embedding were superior to acupuncture.