On December 15, 2025, the U.S. Food and Drug Administration approved the medication Addyi for the treatment of hypoactive sexual desire disorder, or HSDD, in postmenopausal women under the age of 65 — a significant expansion of a drug that had previously been limited to premenopausal patients.
Addyi, also known by its generic name flibanserin, was first approved by the FDA in 2015 for premenopausal women experiencing HSDD. Premenopause refers to the stage of life before menopause, when menstrual cycles are still regular. Postmenopause, by contrast, begins after menopause is complete and menstrual cycles have stopped — a transition most women experience between the ages of 49 and 52.
Low libido is common during menopause and postmenopause. Research suggests that between 40 and 55 percent of women going through menopause report decreased sexual desire, while roughly 9 percent of postmenopausal women meet the diagnostic criteria for HSDD. Until now, treatment options for this group have been limited.
With the expanded approval, Medical News Today spoke with several women’s health experts about how Addyi works and what the decision means for patients.
– -Caption: Pharmacist Meg Wallace shelves bottles of pills Monday morning at Brent’s Drugs in the Woodland Hills Shopping Center on Duling Avenue in Jackson.
Addyi is a non-hormonal prescription medication manufactured by Sprout Pharmaceuticals. Unlike hormone therapy, it works on neurotransmitters in the brain rather than on estrogen or testosterone levels.
“Addyi is a non hormonal medication that works on neurotransmitters in the brain to help regulate mood and increase sex drive,” said Dr. Susan Marie Pacana, a minimally invasive gynecologic surgeon and OB/GYN at Hackensack Meridian Jersey Shore University Medical Center in New Jersey.
Dr. Prudence Hall, an OB/GYN in private practice in Santa Monica and author of Radiant Again & Forever, explained that the drug affects brain chemistry linked to desire.
“After taking it for a month, dopamine and serotonin levels are apparently enhanced, which supposedly increases sexual desire,” Hall said.
Dr. G. Thomas Ruiz, a board-certified OB/GYN at MemorialCare Orange Coast Medical Center in California, said the expanded approval could make a meaningful difference for many of his patients.
“The group of women where I get the biggest complaints of decreased libido is in the 50 to 60 year old age bracket, so potentially this could be a very important medication for them,” Ruiz said.
Pacana, who is also a Menopause Society Certified Practitioner, said the lack of approved treatments for low libido has been a long-standing problem in women’s health.
“Women of all ages present to our office with complaints of low sex drive that affect their relationships, self-esteem, and body image,” she said. “It often is accompanied by feelings of shame, frustration and guilt when women are unable to meet their partner’s sexual expectations.”
One major implication of the FDA’s decision is insurance coverage. While doctors could previously prescribe Addyi off-label to postmenopausal women, many insurers refused to pay for it.
“Previously, I could prescribe it off-label for postmenopausal women, but they were unfairly denied insurance coverage,” Pacana said. “Now, with this official approval, we can finally expect insurers to cover this necessary treatment for a wider population of women.”
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Like all medications, Addyi comes with potential side effects. These include dizziness, nausea, dry mouth, fatigue, headaches, constipation, sleepiness or insomnia, and stomach or back pain.
The drug also carries a black box warning from the FDA. When taken with alcohol or certain medications, Addyi can cause severe low blood pressure and fainting. Because of this risk, experts emphasize the importance of clear guidance for patients.
“They’ve got to make it as least confusing for patients to use as possible,” Ruiz said. “A simple do’s and don’ts information sheet would be useful — for patients and providers alike.”
