OBJECTIVE:To observe the efficacy and safety of mirtazapine in the treatment of perimenopausal syndrome with sleep disorders. METHODS:100 perimenopausal patients with sleep disorders were randomly divided into study group(52 cases) and control group(48 cases). Study group was given Mirtazapine tablet with initial dose of 15 mg,once a day,taking 1-2 hours before going to bed,increased and maintained to 30 mg after 1 week. The control group was given Oryzanol tablet 10 mg after meals,3 times a day. Both groups were treated for 8 weeks. Scores of HAMD-17 and PSQI before and after treatment were ob-served,efficacy of depression and sleep were evaluated and and incidence of adverse reactions in 2 groups was observed. RE-SULTS:After treatment,HAMD-17 scores and PSQI scores in 2 groups were significantly lower than before,and study group was lower than control group,8 weeks<4 weeks<2 weeks,the differences were statistically significant(P<0.05 or P<0.01). Total ef-fective rates of depression and sleep in study group were significantly higher than control group(P<0.05). There was no significant difference in the incidence of adverse reactions(P>0.05). CONCLUSIONS:Mirtazapine can improve the sleep disorders of peri-menopausal syndrome with rapid onset,but the adverse reactions need futher observation.