Abstract： Objective： To observe the clinical effect of Shumian capsules combined with paroxetine hydrochloride tablets for depression complicated with insomnia. Methods：A total of 108 cases of patients with depression complicated with insomnia were selected and divided into the observation group and the control group according to the random number table method，with 54 cases in each group. The observation group was treated with Shumian capsules combined with paroxetine hydrochloride tablets，and the control group was simply treated with paroxetine hydrochloride tablets. Both groups were treated for four weeks. Before and after treatment，the sleep quality，anxiety degree，depressive degree and quality of life in the two groups were evaluated by Pittsburgh Sleep Quality Index(PSQI)，Hamilton Anxiety Scale(HAMA) - 14， Hamilton Depression Scale(HAMD) - 24 and World Health Organization Quality of Life- BREF(WHOQOLBREF). The clinical effects and the incidence of adverse reactions in the two groups were compared. Results：After one，two and four weeks of treatment，the PSQI scores in the two groups were decreased when compared with those before treatment(P＜0.05)，the PSQI score in the observation group was lower than that in the control group at the same period(P＜0.05). After treatment，the scores of HAMA- 14 and HAMD-24 in the two groups were decreased when compared with those before treatment(P＜0.05)，and the scores of HAMA-14 and HAMD-24 in the observation group were lower than those in the control group (P＜0.05). After treatment，the scores of physiology，psychology，social relations，environment and total evaluation in the two groups were increased when compared with those before treatment(P＜0.05)， and the above scores of all dimensions in WHOQOL-BREF in the observation group were higher than those in the control group(P＜0.05). The total effective rate was 88.89% in the observation group，higher than that of 74.07% in the control group(P＜0.05). The incidence of adverse reactions was 16.67% in the observation group and 11.11% in the control group，there being no significance in the difference(P＞0.05). Conclusion： Shumian capsules combined with paroxetine hydrochloride tablets for depression complicated with insomnia can effectively improve sleep quality，quality of life，anxiety and depression，with good safety.