目的 初步探讨夜宁胶囊治疗失眠的临床疗效。方法 选取2012年6月-2012年9月来自于山东中医药大学第二附属医院门诊的失眠患者共140例，随机分为试验组和对照组，试验组105例、对照组35例，试验组口服夜宁胶囊治疗，一次5粒，一日2次；对照组口服养血安神片，一次5片，一日3次，两组均连续用药28 d。分别评价两组的疾病疗效、证候疗效及阿森斯失眠量表。结果 治疗28 d后疾病疗效总有效率试验组为88.57%、对照组为80.00%，两组比较无统计学差异（P>0.05）。治疗28 d后中医证候总有效率试验组为90.48%，对照组为80.00%，两组比较无统计学差异（P>0.05）。结论 夜宁胶囊具有安神、养心的功效，对于阴虚火旺引起的失眠有较好的治疗作用。

Objective To explore the clinical efficacy of Yening Capsules for insomnia. Methods A total of 140 patients with insomnia were selected randomly and divided into treatment group and control group for 105 and 35 patients, and the treatment group was treated with Yening Capsules, five pills, twice daily. The control group was treated with Yangxueanshen Tablets, five tablets, three times daily, for 28 consecutive days. Results After 28 d treatment, the total effective rate was 88.57% in the experimental group and 80.008% in the control group, with no statistic difference (P > 0.05); The total effective rate of traditional Chinese medicinal syndrome was 90.48% in the test group and 80.00% in the control group, with no statistic difference (P > 0.05). Moreover, there was significant difference in efficacy between two groups. Conclusion The clinical trial shows that Yening Capsules has the effect of nourishing heart and calming nerves. For insomnia of fire excess from yin deficiency, Yening Capsules have a better therapeutic effect.