Is Flibanserin Worth the Risks?

February 29, 2016

Is Flibanserin Worth the Risks?

  1. Andrew M. Kaunitz, MD

Review and meta-analysis suggest the answer is no.

  1. Andrew M. Kaunitz, MD

The FDA's approval of flibanserin for hypoactive sexual desire disorder (HSDD) in premenopausal women was accompanied by media attention along with concerns that the medication's modest efficacy might be outweighed by its side effects. In a meta-analysis of eight randomized trials (5 published, 3 unpublished) involving 5914 pre- and postmenopausal women, flibanserin yielded the following outcomes compared with placebo:

  • Mean number of satisfying sexual events per month increased by 0.5 events (from a baseline of 2.5 events monthly).

  • Mean increase in a sexual desire intensity score was 1.6 points (on a 0–84 scale).

  • Mean increase in the desire domain of the Female Sexual Function Index was 0.3 points (on a 1.2–6.0 scale).

All of these differences were statistically significant but small. Among women who received flibanserin, impressions of subjective improvement ranged from minimal to no change. These women were more likely to experience dizziness (risk ratio, 4.0), somnolence (RR, 4.0), nausea (RR, 2.4), and fatigue (RR, 1.6; P<0.05 for all comparisons). Likelihood of discontinuing study medication because of adverse events (AEs) was 2 times greater among women assigned to flibanserin. Risk for a serious AE was similar in both groups.


As the authors appropriately conclude, these findings “suggest that the benefits of flibanserin treatment are marginal, particularly when taking into account the concurrent occurrence of AEs.” In reviewing the regulatory history of flibanserin, editorialists note that “while it is unclear how strongly politics influenced the decision, it is clear that the science was weak.” Although diminished sexual desire is a common complaint, I almost never prescribe flibanserin, given its unfavorable risk/benefit profile. I agree that, for now, management of HSDD is best served by a multidisciplinary “biopsychosocial” approach.

Editor Disclosures at Time of Publication

  • Disclosures for Andrew M. Kaunitz, MD at time of publication Consultant / Advisory board Actavis plc; Bayer AG; Merck Royalties UpToDate Grant / Research support Therapeutics MD; Bayer; Agile; NIH Editorial boards Contraception; Menopause; Contraceptive Technology Update; OBG Management; Medscape OB/GYN & Women’s Health Leadership positions in professional societies North American Menopause Society (Treasurer)


Reader Comments (2)

Maarten VASBINDER Physician, Family Medicine/General Practice, Retired

When I see these data, my conclusion is, that Fibranserin should be taken off the market

Matthew Anderson Physician, Family Medicine/General Practice, Montefiore Medical Center

And, of course, you can't drink alcohol while using fibanserin. Very practical that one. One wonders what the FDA committee members do after work. Probably go home and read medical journal articles.

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