OBJECTIVE: To evaluate the effect of Guizhi Gancao Longgu Muli Tang (GGLMT), a decoction prepared with herbal medicine of Traditional Chinese Medicine, on sleep disturbances in women with menopause. METHODS: Totally 162 participants were recruited for the treatment of sleep difficulty from February, 2012 to December, 2014. Decoction of 200 mL was taken by every participant twice daily in half an hour after lunch and dinner during two weeks. Sleep quality was assessed by Pittsburg sleep quality index (PSQI) and menopausal symptoms and quality of life were evaluated by the menopause rating scale (MRS) and the Chinese version of World Health Organization quality of life-BREF at the final fellow -up in the fourth weekend after beginning. RESULTS: The average scores of PSQI had reduced from' (13.82 +/- 4.97) to (8.14 +/- 3.19), 95% CI (-4.87, -3.05) after 2-week GGLMT treatment in the fourth week. GGLMT improved symptoms in patients with more severe conditions (MRS >= 16). Three adver'se drLig reaction, mouth ulcer, constipation, and folliculitis, might be related with GGLMT and disappeared after withdrawals of the treatment. CONCLUSION: For menopausal.women suffering from chronic sleep disturbances, our findings suggest that two weeks treatment of GGLMT was safe and effective. (C) 2017 JTCM. All rights reserved.