The U.S. Food and Drug Administration (FDA) has recently granted expanded approval for flibanserin to treat hypoactive sexual desire disorder (HSDD) in postmenopausal women under age 65. This marks a momentous occasion: the first time an oral treatment for low sexual desire is available to postmenopausal women.
Flibanserin is a non-hormonal agent thought to act on serotonergic and dopaminergic pathways involved in sexual desire. Typically, 100mg is taken nightly and carries a boxed warning about the risk of hypotension and syncope, especially when combined with alcohol or CYP3A4 inhibitors. Patients must avoid alcohol close to dosing and follow specific timing recommendations. Common side effects include dizziness, nausea, dry mouth, fatigue, and insomnia.
Flibanserin was originally approved in 2015 for premenopausal women and remains the only FDA-approved pill for HSDD. The updated label follows a Priority Review designation and comes after global regulatory momentum: Canada approved postmenopausal use in 2021. Approval was based on safety and efficacy data from the largest clinical trial program in women’s sexual health to date.
Clinically, this approval closes a long-standing treatment gap in sexual medicine. While HSDD affects an estimated 40% of women, options have been limited—especially after menopause. This decision reinforces the need for equitable, evidence-based care across the lifespan and provides a new option for patients whose sexual health concerns have historically been overlooked.