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Flibanserin, the Drug for Female Sexual Desire, Approved for Marketing

Last updated Aug. 18, 2015

Approved by: Maulik P. Purohit MD MPH

Check out this great explanation picked by DoveMed. Dr. Jeffrey Albaugh, Director of the William D. and Pamela Hutul Ross Clinic for Sexual Health discusses the causes of desire disorder and treatment with testosterone.


The US Food and Drug Administration (FDA) has approved Flibanserin to treat generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

Female Hypoactive Sexual Desire Disorder (HSDD) is defined as a lack of desire for sex that leads to distress and interpersonal difficulties in women. According to the North American Menopause Society, HSDD is the most prevalent sexual disorder in women of all ages. Surgically menopausal women between 20-49 years of age are reported to be more prone to HSDD compared to those who are naturally menopausal.

Flibanserin is a drug that acts on the brain neurotransmitters: dopamine, serotonin, and norepinephrine. The medicine increases the levels of dopamine and norepinephrine while decreasing the levels of serotonin. Owing to concerns about its efficacy, as well as drug safety issues, the FDA rejected the marketing authorization twice for the drug. However, the manufacturer conducted more research and re-submitted the information to the FDA. Based on the collective data, the FDA advisory committee concluded that women using the drug reported a modest increase in satisfactory sexual events when compared to women on placebo and voted 18 to 6 to recommend that the FDA approve Flibanserinfor enhancing sexual desire in pre-menopausal women suffering from HSDD.

Accepting the recommendation by the Advisory Committee, the FDA has approved Flibanserin for marketing. Since there are still concerns of serious adverse events, the drug will be marketed with a “Risk Evaluation and Mitigation Strategy” in place for safe use. The drug will also be marketed with a boxed warning.

According to the FDA, the most common adverse reactions associated with the use of Flibanserin are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth. However, the following warnings about Flibanserin have to be taken into consideration as well, to avoid serious adverse events:

Severe low blood pressure and fainting could occur if
  • Alcohol is consumed while on Flibanserin
  • Women on moderate or strong CYP3A4 inhibitors also take Flibanserin
  • Women with liver impairments take Flibanserin

Since adverse events are a distinct possibility with the use of Flibanserin, it will only be available through certified medical practitioners and certified pharmacies at this time. Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, states in the Press Release, “Patients and prescribers should fully understand the risks associated with the use of Addyi (Flibanserin) before considering treatment.”

Dr. Janet Woodcock says, “Today’s approval provides women distressed by their low sexual desire with an approved treatment option. The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

If women using Flibanserin experience adverse events, they are requested to contact FDA at:

Telephone-1-800-FDA-1088

Online: www.fda.gov/MedWatch  


By Mangala Sarkar, PhD

Primary Reference

U.S. Food and Drug Administration. (n.d.). Retrieved August 19, 2015, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm

DoveMed Resources

Female Hypoactive Sexual Desire Disorder. (n.d.). Retrieved August 19, 2015, from http://www.dovemed.com/diseases-conditions/female-hypoactive-sexual-desire-disorder/

The US Food And Drug Administration's Advisory Committee Recommends Approval Of Flibanserin, A Drug That Improves Libido In Women. (n.d.). Retrieved August 19, 2015, from http://www.dovemed.com/current-medical-news/fda-flibanserin/

Additional Reference

(n.d.). Retrieved August 18, 2015, from http://www.menopause.org/docs/default-document-library/hsddkingsberg.pdf?sfvrsn=2

Reviewed and Approved by a member of the DoveMed Editorial Board
First uploaded: Aug. 18, 2015
Last updated: Aug. 18, 2015