Objective: To evaluate the efficacy of Bailemian capsule combined with self-help cognitive behavioral therapy (CBTI-SH) in treatment of chronic insomnia. Methods: Approved by the Ethics Committee of the hospital, 60 patients with chronic insomnia were randomly divided into two groups, the test group (Bailemian capsule combined with CBTI-SH) and the control group (CBTI-SH alone). Each group contained 30 cases. After 4 weeks for therapy, the sleep quality, mood and adverse reactions of treatment in patients were evaluated by sleep diary, sleep severity index scale (ISI), self-rating anxiety scale (SAS), self-rating depression scale (SDS) and treatment emergent symptom scale (TESS) respectively. The data were statistically analyzed. Results: The total effective rate in the test group was significantly higher than that of the control group (73.3% vs 46.7%, P<0.05). Compared to the control group, the sleep onset latency was significantly shorten [(38.3±13.1) vs (27.5±9.8) min, P<0.05], while the sleep efficiency were increased markedly [(76.6±5.7)% vs (80.5±6.6)%, P<0.05] in the test group. In the test group, the sleep onset latency, the total sleep time, the time in bed and sleep efficiency both improved significantly after treatment [(27.5±9.8) vs (56.2±19.4) min, (334.4±41.6) vs (310.8±31.7) min, (415.6±38.9) vs (446.9±39.9) min, (80.5±6.6)% vs (69.6±4.9)%, all P<0.05], while in the control group, the sleep onset latency, the time in bed and sleep efficiency also improved significantly after therapy [(38.3±13.1) vs (55.2±16.2) min, (430.4±32.6) vs (452.4±34.4) min, (76.6±5.7)% vs (69.9±5.2)%, all P<0.05]. After combined treatment, the SAS and SDS scores [(51.5±6.5) vs (55.0±5.8), (52.0±5.3) vs (55.3±4.4), both P<0.05] both decreased significantly than those of the control group, at the same time, the SAS and SDS scores decreased significantly after treatment in both the test group and the control group [(51.5±6.5) vs (61.5±4.8), (52.0±5.3) vs (60.2±4.5), (55.0±5.8) vs (62.5±3.7), (55.3±4.4) vs (62.2±3.7), all P<0.01]. Conclusion: The efficacy of Bailemian capsule combined with CBTI-SH in the treatment of chronic insomnia is more effective.