Abstract：Objective：To observe the clinical effect and safety of Jiaotai pills for insomnia of non-interaction between the heart and the kidney type in perimenopausal period. Methods：A randomized， double-blind， placebo-controlled clinical trial design was adopted. A total of 32 cases of perimenopausal women with insomnia of non-interaction between the heart and the kidney type were randomly divided into two groups， with 16 cases in each group. The control group was treated with placebo， and the observation group was treated with granules of Jiaotai pills. Both groups were treated for one week. Before and after treatment， the changes of the scores of Pittsburgh Sleep Quality Index(PSQI)， modified Kupperman scale， Chinese medicine syndromes，and the levels of melatonin，adenosine and follicle-stimulating hormone(FSH) in serum in the two groups were compared. Results： After treatment， the scores of PSQI， modified Kupperman scale and Chinese medicine syndromes in the observation group were significantly decreased，differences being significant(P＜0.05)，and the scores of PSQI， modified Kupperman scale and Chinese medicine syndromes in the observation group were lower than those in the control group， differences being significant(P＜0.05). After treatment，the levels of melatonin and adenosine in serum in the observation group were significantly increased when compared with those in the control group， differences being significant(P＜0.05)， and the levels of melatonin and adenosine in serum in the observation group were significantly better than those in the control group， differences being significant(P＜0.05). There was no significant difference in the comparison of FSH in the two groups before and after treatment and between the two groups after treatment(P＞0.05). There was no treatment- related adverse reaction in the two groups， and no significant abnormality in blood routine， liver and kidney function and other indicators of patients. Conclusion： Jiaotai pills is effective in the treatment of insomnia of non- interaction between the heart and the kidney type in perimenopausal period， and can improve clinical symptoms and increase the levels of melatonin and adenosine in serum，with great safety.