ObjectiveTo systematically review the efficacy and safety of flibanserin for hypoactive sexual desire disorder in premenopausal women. MethodsWe searched PubMed, EMbase, MEDLINE, The Cochrane Library (Issue 7, 2014), CBM, CNKI, VIP and WanFang Data from their inception to August 2014, to collect randomized controlled trials (RCTs) on the effectiveness and safety of flibanserin for hypoactive sexual desire disorder in premenopausal women. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. And then, meta-analysis was performed using RevMan 5.3 software. ResultsA total of 4 RCTs involving 3 881 patients were included. The results of meta-analysis showed that:compared with the placebo group, the flibanserin group was superior in increasing the number of satisfying sexual events (SSE) (MD=0.72, 95%CI 0.51 to 0.92, P<0.000 01), improving the eDiary desire score (MD=2.21, 95%CI 1.45 to 2.97, P<0.000 01), FSFI domain score (MD=0.29, 95%CI 0.24 to 0.35, P<0.01) and FSFI total score (MD=1.82, 95%CI 1.47 to 2.17, P<0.000 01), and decreasing the FSDS-R item 13 score (MD=-0.24, 95%CI -0.31 to -0.17, P<0.000 01) and FSDS-R total score (MD=-2.70, 95%CI -3.43 to -1.96, P<0.000 01). However, the incidence of adverse events in the flibanserin group was higher than that of the placebo group (OR=1.31, 95%CI 1.11 to 1.54, P=0.001). ConclusionThe current evidence suggests that, in premenopausal women with HSDD, flibanserin treatment is effective but may increase the incidence of adverse events.