Objective:To explore the clinical effect and safety of intrinsic-nourishing exercise and oral Chinese medicine combined with conventional western medicine therapy in the treatment of perimenopause with insomnia.Methods:Prospective cohort study. A total of 60 perimenopause with insomnia visiting the Hebei Medical Qigong Hospital were enrolled as the research objects between June 2019 and June 2021. According to random number table method, they were divided into the control group and the observation group, 30 in each group. The control group was treated with oral estazolam tablets, while the observation group was treated with intrinsic-nourishing exercise combined with oral Chinese medicine on basis of the control group. All the patients were treated for 4 weeks as a course, and totally 2 courses. The levels of serum estradiol (E 2), FSH, and LH were detected by automatic chemiluminescence immunoassay analyzer. Pittsburgh sleep quality Index (PSQI) was used to evaluate sleep quality, and the quality of life was evaluated by the MOS 36-item Short Form Health Survey (SF-36). And the responsive rates, sleep quality, scores of TCM symptoms, and adverse reactions were compared before and after treatment. Results:The total response rate of observation group was significantly higher than that of the control group (90.0% vs. 66.7%; χ2=4.81, P<0.05). After treatment, PSQI scores of sleep quality, time to fall asleep, sleep duration, sleep efficiency, sleep disturbance, use of hypnotics, and daytime function in the observation group were significantly lower than those in the control group ( t=14.11, 12.49, 9.88, 13.54, 9.47, 14.11, 17.91, P<0.01). After treatment, the TCM symptom scores of insomnia with more dreams, waist and knee soreness, five upsets, fatigue and forgetfulness in the observation group were significantly lower than those in the control group ( t=9.51, 13.08, 16.17, 12.81, P<0.01). After treatment, the E 2 [(35.16±3.61) mmol/L vs. (31.06±3.12) mmol/L, t=4.71] in the observation group was significantly higher than that of the control group ( P<0.01), while the FSH [(69.61±6.04) U/L vs. (73.26±7.41) U/L, t=2.09], and LH [(32.21±3.35) U/L vs. (36.04±3.49) U/L, t=4.34] in the observation group were significantly lower than those in the control group ( P<0.05 or P<0.01). At 4 and 8 week after treatment, the SF-36 scores in the observation group were significantly higher than those in the control group ( t=6.30, 4.36, P<0.01). During treatment, 16.7% (5/30) adverse reaction happened in the observation group, while 10.0% (3/30) in the control group, but there was no statistical significant difference between two groups ( χ2=0.56， P=0.448). Conclusion:The intrinsic-nourishing exercise and oral Chinese medicine combined with conventional western medicine therapy can significantly improve clinical curative effect, improve sleep quality and TCM symptoms, regulate hormones and quality of life in perimenopause with insomnia.