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In January 2026, the U.S. Food and Drug Administration (FDA) expanded the indication for flibanserin to include postmenopausal women younger than 65 years with hypoactive sexual desire disorder.
Flibanserin is a centrally acting, nonhormonal agent that is thought to affect neural pathways involved in sexual desire. The drug was first approved by the FDA in 2015 for the treatment of acquired hypoactive sexual desire disorder in premenopausal women. Now, the indication has been expanded to postmenopausal women under age 65.
Data from two randomized trials (originally published in 2014 and 2017) led to this expanded indication:
In the first trial, 950 postmenopausal women were assigned to either flibanserin 100 mg nightly or…