FDA expands approval of Addyi to postmenopausal women up to age 65

The U.S. Food and Drug Administration on Monday expanded the approval of Addyi, a once-daily pill intended to boost female libido, to postmenopausal women up to age 65. Addyi was first approved about a decade ago for premenopausal women who report emotional distress related to low sex drive. The drug is marketed by Sprout Pharmaceuticals.

The approval comes with safety warnings, including a boxed label about the risks of taking Addyi with alcohol. Drinking while on the medication can cause dangerously low blood pressure and fainting. The label advises patients who plan to drink to avoid the drug or to wait several hours after drinking before taking a dose, or to skip doses if alcohol consumption is heavy. Sprout CEO Cindy Eckert welcomed the decision as a shift in how women’s sexual health is understood and prioritized.

The medical condition hypoactive sexual desire disorder has been recognized since the 1990s and is thought to affect a meaningful portion of American women, according to surveys. After the blockbuster success of Viagra for men in the 1990s, drugmakers pursued potential therapies for sexual dysfunction in women, though diagnosing the condition is complex because libido can be influenced by relationship factors, medical conditions, and mental health. Clinicians must rule out a range of issues before prescribing medication.

The FDA previously rejected Addyi twice, citing modest effectiveness and safety concerns, before granting approval in 2015 for premenopausal women. The 2015 decision followed a high-profile lobbying push by supporters who framed the lack of options for female libido as a broader health and rights issue. In 2019, the agency approved a second drug for low female libido, an on-demand injectable that targets a different set of brain chemicals. The current expansion to postmenopausal women up to age 65 adds another treatment option for a population affected by hormonal changes after menopause.

The FDA’s update reflects ongoing efforts to address women’s sexual health as a legitimate medical topic and to provide clinicians with tools while balancing safety considerations.