Objective:To evaluate the clinical effect of Huanglian-Wendan Decoction combined with Estazolam tablets in the treatment of post-stroke sleep disorders (PSSD) with syndrome of internal disturbance of phlegm-heat. Methods:A total of 96 patients with PSSD who met the inclusion criteria in the People's Hospital of Shenzhen Luohu District from September 2016 to June 2018 were randomly divided into the control group (47 cases) and the study group (49 cases) by random number table method. The control group took Estazolam tablets based on routine treatment, and the intervention group took Huanglian-Wendan Decoction based on the control group. Both groups were treated for 2 weeks. The TCM syndromes were recorded and scored before and after the treatment. The anxiety symptoms were assessed by Hamilton Anxiety Scale (HAMA) and the depression symptoms were assessed by Hamilton Depression Scale (HAMD) respectively. Sleep quality was assessed by Pittsburgh Sleep Quality Index (PSQI). The level of brain-derived neurotrophic factor (BDNF) was detected by ELISA, the level of 5-hydroxytryp-tamine (5-HT) was detected by high performance liquid-phase electrochemical detector. The adverse reactions were recorded and clinical efficacy was evaluated. Results:The total clinical effective rate of the intervention group was 91.8% (45/49), and 76.6% (36/47) in the control group. There was significant difference between the two groups ( χ2=4.227, P=0.040). After the treatment, the scores of HAMA, HAMD and PSQI in the intervention group were significantly lower than that of the control group ( t value were 4.081, 4.869 and 3.900, respectively, all Ps<0.001). The levels of serum BDNF (42.36 ± 6.78 ng/ml vs. 33.98 ± 6.41 ng/ml, t=6.217), 5-HT (127.21 ± 12.39 ng/ml vs. 101.46 ± 11.70 ng/ml, t=10.460) were significantly higher than that of the control group ( P<0.01). During the treatment, the incidence of adverse reactions was 14.9% (7/47) in the control group and 8.2% (4/49) in the intervention group, and there was no significant difference between the two groups ( χ2=1.071, P=0.301). Conclusions:Huanglian-Wendan Decoction combined with Estazolam tablets can improve the clinical symptoms, relieve anxiety and depression of PSSD patients with syndrome of internal disturbance of phlegm-heat, and improve sleep quality and clinical efficacy.