Addyi® (flibanserin) is the first Food and Drug Administration (FDA) approved pill for low sexual desire in women. It is manufactured by Sprout Pharmaceuticals. It is now approved for the treatment of hypoactive sexual desire disorder (HSDD) in women under 65 years of age, including postmenopausal women. This decision addresses a long-standing research gap in healthcare related to frustrating low sexual desire in postmenopausal women. This approval marks a historic milestone in women’s health. According to the Mayo Clinic, HSDD affects approximately 40% of women and is the most common type of sexual dysfunction.
Flibanserin is a non-hormonal medicine prescribed by more than 30,000 physicians in the U.S. It works by modulating the neurotransmitters involved in sexual response. It acts as a 5-hydroxytryptamine (5-HT)2A antagonist and 5-HT1A agonist. It also shows moderate activity at other receptors like dopamine D4 and serotonin 5-HT2C, 5-HT2B receptors. This drug was first approved in 2015 for premenopausal women. Its efficacy and safety were further supported by Health Canada’s 2021 approval for postmenopausal women.
The current approval of Addyi® is based on results data from the largest clinical trials. The efficacy of this drug was evaluated in four randomized, placebo-controlled, double-blinded, 24-week clinical studies. In premenopausal women with HSDD, three trials like NCT00360529 (Study 1, n = 570), NCT00360555 (Study 2, n = 737), and NCT00996164 (Study 3, n = 1,068) showed significant increase in satisfying sexual events (SSEs) for treatment group compared to placebo (+0.6 to +1.0 per month; p<0.01 to p<0.0001). Female sexual function index (FSFI) desire improved significantly in Study 3 and consistently across trials. Moreover, the female sexual distress scale-revised (FSDS-R) increased by -0.3 to -0.4 in the treatment group compared to the control.
Study 5 clinical trial did not assess the recommended 100 mg bedtime dose of Addyi®. In Study 6 (NCT00996372), postmenopausal women aged <65 years with HSDD (n = 902) who received Addyi® experienced greater improvement in SSEs (+0.9 vs +0.4; p<0.025), FSFI desire (+0.3; p<0.0001), and distress (−0.2; p<0.01) compared to placebo. Driving performance was unaffected in a crossover safety study (n = 83). Study 7 was terminated early.
The recommended dose of Addyi® is 100 mg once daily at bedtime, as daytime use increases the safety risks. Treatment should be discontinued after 8 weeks if no clinical benefits are observed. Common adverse drug reactions include dry mouth, fatigue, dizziness, insomnia, nausea, and somnolence. This drug carries a boxed warning for syncope and hypotension, particularly when taken with alcohol, CYP3A4 inhibitors, or in patients with hepatic impairment. Patients are advised to wait at least 2 hours after consuming one or two alcoholic drinks before dosing or to skip the dose after consuming ≥3 drinks.
Sprout Pharmaceuticals CEO Cindy Eckert said that the expanded FDA approval of Addyi® reflects a decade of advocacy for prioritizing science over stigma in women’s sexual health. Clinical experts emphasized that menopause does not mark the end of sexuality and praised the approval as a meaningful validation of women’s experience.
Reference:
- Sprout Pharmaceuticals. Historic first in women’s sexual health: FDA grants approval for Addyi® (flibanserin) in postmenopausal women. PRNewswire. Published December 15, 2025. Accessed December 17, 2025. Historic First in Women’s Sexual Health: FDA Grants Approval for Addyi® (flibanserin) in Postmenopausal Women
- Sprout Pharmaceuticals. Addyi-Package insert. Revised 2025. Accessed on December 17, 2025. 12.2025 PI.docx
