Objective To observe the therapeutic effect of Wenxin Granules（granules to steady heart）on insomnia with qi-yin deficiency syndrome.Methods In this randomized

comparative and multicenter study

totally 302insomnia patients with qi-yin deficiency syndrome were randomized into treatment group of 199cases and control group of 103cases.The treatment group was given Wenxin Granules

5g once

three times daily.The control group was given Qiye Shen’an Tablet（tablet of total saponins of Panax Notoginseng）

100mg once

three times daily.The therapeutic effect

sleep efficiency

syndrome scores and safety were observed.Results The total effective rate of the treatment group and the control group was 91.46%and 70.87% respectively.There was significant difference between groups（P<0.05）.Both groups could significantly improve the sleep efficiency（P<0.01）

especially the treatment group（P<0.01）.The scores of symptoms were significantly improved in both groups after treatment（P<0.01）.Both groups were equally effective in relieving short of breath（P>0.05）.There were significant differences between groups in other symptom scores（P<0.01）.Conclusion Wenxin Granules is more effective and safe for insomnia with qi-yin deficiency syndrome than Qiye Shen’an Tablet.