FDA Approves Addyi for Postmenopausal Women

Expanded Indication for Addyi

On December 15, 2025, the U.S. Food and Drug Administration (FDA) granted approval for Addyi (flibanserin) to treat hypoactive sexual desire disorder (HSDD) specifically in postmenopausal women under the age of 65. This follows the drug’s initial approval in 2015, when it was designated for premenopausal women.

Understanding HSDD in Women

Research indicates that between 40% and 55% of women experiencing menopause report low sexual desire, with approximately 9% diagnosed with HSDD. Menopause typically occurs between the ages of 49 and 52, marking a significant transition in a woman’s reproductive life.

Menopause and Its Effects on Libido

Menopause represents the phase in a cisgender woman’s life when menstrual cycles cease. Following this period, many individuals may face challenges with sexual desire. While HSDD can occur at any age, it is particularly prevalent during and after menopause.

Expert Insights on Addyi’s Approval

With the recent approval of Addyi for postmenopausal women, Medical News Today consulted three women’s health experts. They provided insights into the mechanism of Addyi, its potential side effects, the implications of this approval for menopausal women, and alternative non-medication strategies to address low libido.