FDA Expands Approval of Flibanserin for Postmenopausal Women’s Sexual Health

The FDA approved the expanded use of flibanserin (Addyi) for the treatment of hypoactive sexual desire disorder (HSDD) in women younger than 65 years. This marks the first and only FDA-approved treatment for this condition.¹

“This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized," Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, said in a news release.¹ "Over the years, we've pushed for the science to speak louder than the stigma—and today's approval shows how far we've come. I want to congratulate the FDA for recognizing what millions of women have long deserved: equitable, science-backed care at every stage of life.”

According to an article in Medicina (Kaunas), sexual function worsens the longer a person has menopause. The most frequently reported symptom includes low sexual desire for approximately 40% to 55% of women, the study authors said. Declining levels of estrogen and androgens play a role in this impairment; however, investigators stated that many psychological and relational changes in regard to aging should also be taken into account.²

"I was in the room a decade ago when Addyi became the historic first for women's sexual health, and I have been waiting for this moment ever since," Rachel Rubin, MD, urologist and sexual medicine specialist, said in the news release.¹ "So many of my postmenopausal patients have carried the weight of frustrating low sexual desire with no FDA-approved option to turn to. Today's decision finally includes them. It's a critical acknowledgment that their pleasure, their well-being, and their quality of life matter—and that science-backed care should be available to every woman, at every stage of her life."

The expanded approval was based on 3 North American phase 3 trials among premenopausal women with HSDD, which also supported the approval of the drug in 2015. Investigators said that flibanserin demonstrated improvements in desire for sex, reduced distress from the loss of sexual desire, and increased the number of satisfying sexual events.^1,3

As for safety, flibanserin is based on clinical trial data in more than 8000 women, with 1000 of them being exposed to treatment for at least 1 year. Further, 2500 premenopausal women with acquired and generalized HSDD were in clinical trials, and over 850 were treated for at least 12 months. Approximately 13% of patients receiving the drug and 6% receiving the placebo discontinued treatment due to adverse events. Further, the most common adverse events for flibanserin included dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth. Hypertension and syncope were rarely seen with flibanserin; however, they occurred more frequently when the drug was taken in the morning and when coadministered with alcohol or certain other drugs.³

"Menopause does not mark the end of a woman's sexuality, but for too long, medicine has treated it that way," Mary Claire Haver, MD, FACOG, MSCP, OB-GYN, said in the news release.¹ "This FDA approval is a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire. Expanding Addyi's approval is historic in validating women's experiences and ensuring that millions of women suffering have real choices when it comes to their sexual health."

READ MORE: Women's Health Resource Center

Are you ready to elevate your pharmacy practice? Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips straight to your inbox.

REFERENCES

1. Historic first in women’s sexual health: FDA grants approval for Addyi (flibanserin) in postmenopausal women. Sprout Pharmaceuticals. News release. December 15, 2025. Accessed December 15, 2025. https://www.prnewswire.com/news-releases/historic-first-in-womens-sexual-health-fda-grants-approval-for-addyi-flibanserin-in-postmenopausal-women-302642397.html

2. Scavello I, Maseroli E, Di Stasi V, Vignozzi L. Sexual Health in Menopause. Medicina (Kaunas). 2019 Sep 2;55(9):559. doi: 10.3390/medicina55090559. PMID: 31480774; PMCID: PMC6780739.

3. Sprout Pharmaceuticals receives FDA approval of Addyi (flibanserin 100 mg). News release. Sprout Pharmaceuticals. August 18, 2015. Accessed December 15, 2025. https://www.prnewswire.com/news-releases/sprout-pharmaceuticals-receives-fda-approval-of-addyi-flibanserin-100-mg-300130368.html