Objective To observe the efficacy and safety of Zhenzao Capsule [capsule of Suanzaoren（ Semen Ziziphi Spinosae

酸枣仁） and Zhenzhumu（ Concha Margaritifera

珍珠母） ] for elderly patients with insomnia of effulgent yin deficiency fire pattern. Methods Totally 66 elderly patients with insomnia of effulgent yin deficiency fire pattern were randomized into the treatment group and control group

with 33 in each. The treatment group and control group was given 1. 9 g of Zhenzao Capsule and 2. 0 g of Shumian Capsule（ capsule for insomnia） respectively 30min before bedtime. The treatment lasted for 4 weeks. The total sleep time

sleep latency time

numbers of awakenings and non-rapid eye movement（ REM） sleep time were observed before and after treatment according to polysomnography. The TCM pattern scores were recorded before and after treatment. The therapeutic effect and TCM pattern efficacy were evaluated and the adverse reactions were recorded after treatment. Results The total effective rate of the treatment group and control group was 87. 88% and 81. 82% respectively

with no significant difference between groups（ P > 0. 05）. The total TCM pattern efficacy in the treatment group and control group was 90. 90% and 75. 76% respectively

with significant difference between groups（ P < 0. 05）. The TCM pattern scores in both groups were significantly decreased after treatment（ P < 0. 05）

especially in the treatment group（ P < 0. 05）. The total sleep time

sleep latency time

numbers of awakenings and non-REM sleep time were significantly improved in both groups after treatment（ P < 0. 05 or P < 0. 01）

especially sleep latency time

numbers of awakenings

sleep time

moderate + deep sleep time in the treatment group（ P < 0. 05）. There was no adverse reaction in both groups. Conclusion Zhenzao Capsule is effective and safe for insomnia with effulgent yin deficiency fire pattern in elderly. It can regulate the sleep structure

increase the total sleep time and shorten the sleep latency time.