The US Food and Drug Administration has approved Addyi (flibanserin 100 mg) for the treatment of hypoactive sexual desire disorder in women younger than 65 years, including postmenopausal women. The December 15, 2025, decision represents the first FDA approval of Addyi  for this indication in postmenopausal women.

Addyi, manufactured by Sprout Pharmaceuticals, was originally approved in 2015 for premenopausal women with hypoactive sexual desire disorder. The expanded indication follows Priority Review designation granted earlier in 2025, a status reserved for drugs addressing serious unmet medical needs. Health Canada approved similar expanded use in 2021.

The medication is a non-hormonal agent that acts on neurotransmitters involved in sexual response. It is prescribed by more than 30,000 US healthcare professionals. According to the Mayo Clinic, hypoactive sexual desire disorder affects an estimated 40% of women and represents the most common form of female sexual dysfunction.

The approval was supported by clinical trial data, described in the announcement as the largest and most rigorous trials conducted in women's sexual health to date.

Safety Considerations

The prescribing information includes a boxed warning regarding severe hypotension and syncope. Contraindications include alcohol consumption within 2 hours of dosing, concomitant use of certain interacting medications, and hepatic impairment. Common adverse effects include dizziness, difficulty falling asleep or staying asleep, nausea, dry mouth, and tiredness. The medication is not indicated for use in men, children, or for enhancement of sexual performance.

Source: prnewswire