To evaluate effect of Bailemian capsule in improving insomnia with liver qi stagnation and yin deficiency syndrome. Methods： A randomized, double-blind, parallel-group, multi-center clinical research was conducted involving 10 hospitals and 454 cases of insomnia patients with liver qi stagnation and yin deficiency. The 342 patients in experimental group received Bailemian capsule and Tianwangbuxin pills simulant. The 112 cases in control group were given Tianwangbuxin pills and Bailemian capsules simulation agent. 4 weeks were one course of treatment, and 5 weeks were observation duration. Results： The Pittsburgh Sleep Quality Index score and the efficacy of TCM symptoms in the experimental group were better than that of the control group, and there was a statistically significant difference between two groups. Conclusion： Bailemian has good clinical efficacy and safety in treating insomnia with liver qi stagnation and yin deficiency.