FDA
Addyi now approved for low sexual desire in postmenopausal women
On December 15, 2025, FDA approved Addyi (flibanserin) for the treatment of hypoactive sexual desire disorder (HSDD) in women <65 years.
Previously, Addyi had only been approved for use in premenopausal women.
Efficacy
Efficacy of Addyi for the treatment of acquired, generalized HSDD in naturally postmenopausal women <65 years of age was established in the 24-week, randomized, double-blind, placebo-controlled SNOWDROP trial (NCT00996372). The trial had two co-primary efficacy endpoints — one for satisfying sexual events (SSEs) counts and one for the desire domain of the Female Sexual Function Index (FSFI Desire) — and a secondary endpoint that measured bother (a component of distress) related to sexual desire using question 13 of the Female Sexual Distress Scale-Revised (FSDS-R).
At baseline, mean number of SSEs was 2.0, mean FSFI Desire score was 1.8, and mean score for FSDS-R question 13 was 3.3.
Flibanserin led to a notable increase in the average number of SSEs compared with placebo (change from baseline: 0.9 vs. 0.6; difference of 0.4; 95% confidence interval [CI], 0–0.8; P <0.025) and also improved the mean FSFI Desire score (change from baseline: 0.7 vs. 0.4; difference of 0.3; 95% CI, 0.2–0.5; P <0.0001). Additionally, patients receiving flibanserin showed a greater reduction in FSDS-R question 13 scores, with a mean improvement of -0.8 points vs. -0.6 points for placebo (difference of -0.2; 95% CI, -0.4 to -0.1; P <0.01).
Safety
Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation, and dry mouth.
Sources:
Historic first in women’s sexual health: FDA grants approval for Addyi® (flibanserin) in postmenopausal women. [News release]. 2025. https://www.prnewswire.com/news-releases/historic-first-in-womens-sexual-health-fda-grants-approval-for-addyi-flibanserin-in-postmenopausal-women-302642397.html
Addyi (flibanserin). [package insert]. Sprout Pharmaceuticals. https://addyi.com/wp-content/uploads/2025/12/2025-12-11_PI_02.pdf Revised December 2025. Accessed December 16, 2025.