US EditionFDA OKs libido-boosting pill for older women who have gone through menopause
Addyi becomes the first FDA-approved treatment for low sexual desire in postmenopausal women under 65, addressing a condition affecting an estimated 10% of women, experts say.
- On Dec. 15, 2025, the U.S. Food and Drug Administration approved Addyi for postmenopausal women under age 65, Sprout Pharmaceuticals announced.
- After a decade of regulatory scrutiny, the expanded approval follows FDA Priority Review earlier this year and builds on flibanserin's 2015 approval plus published SNOWDROP trial data.
- Clinical data show that a 24-week randomized, double-blind, placebo-controlled trial reported significant increases in satisfying encounters and desire .
- Sprout CEO Cindy Eckert framed the decision as a milestone, saying `This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized`, and Addyi is already prescribed by over 30,000 U.S. healthcare professionals.
- Despite approval, safety measures such as prior Risk Evaluation and Mitigation Strategy and alcohol guidance remain central, as the drug retains a boxed warning about alcohol-linked hypotension and fainting while some psychologists question the HSDD diagnosis.
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81 Articles
A Pill for Sexual Desire Reaches a New Group of Women
On Dec. 15, Sprout Pharmaceuticals received approval to use its pill, Addyi (flibanserin), to treat low sexual desire in women who are past menopause. Addyi works by addressing neurotransmitters like dopamine, norepinephrine, and serotonin in the brain, balancing them to stimulate sexual desire signals while suppressing inhibitory ones. The pill has been approved by the U.S. Food and Drug Administration (FDA) since 2015 to treat hypoactive sexua…
Diagnosis of hypoactive sexual desire disorder is complex and requires a thorough evaluation of psychological and physiological factors
MedPage Today
Anti-Aging, Acupuncture and Health NewsFDA Approves Sexual Desire Drug for Postmenopausal Women
(MedPage Today) -- The FDA expanded the approval of flibanserin (Addyi), a drug that treats low sexual desire in women, to now include some postmenopausal women, drugmaker Sprout Pharmaceuticals announced on Monday. Flibanserin is a mixed 5-HT1A...
US health officials expanded approval of a much-debated drug intended to boost female sex drive, announcing that the daily pill can now be taken by women over 65.
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