FDA Approval Signals Broader Recognition of Sexual Health in Aging Women

Flibanserin 100 mg (Addyi; Sprout Pharmaceuticals) received FDA approval for the treatment of hypoactive sexual desire disorder (HSDD) in women less than 65 years old. The approval represents a historic first in the treatment of sexual health for postmenopausal women—closing a gap in care and marking a shift toward acknowledging sexual health as an integral component of aging and quality of life.

“I was in the room a decade ago when [flibanserin] became the historic first for women's sexual health, and I have been waiting for this moment ever since," Rachel Rubin, MD, urologist and sexual medicine specialist, said in a news release. "So many of my postmenopausal patients have carried the weight of frustrating low sexual desire with no FDA-approved option to turn to. Today's decision finally includes them. It's a critical acknowledgment that their pleasure, their well-being, and their quality of life matter—and that science-backed care should be available to every woman, at every stage of her life."¹

What Is HSDD?

According to the Mayo Clinic, hypoactive sexual desire disorder (HSDD) is the most common form of sexual dysfunction in women, affecting approximately 40% of women. The condition is characterized by a persistent lack of sexual interest or desire that causes personal distress or interpersonal difficulties. Its etiology is multifactorial, encompassing physical and psychological contributors such as chronic diseases (eg, cancer, multiple sclerosis, and diabetes), neurotransmitter imbalances, medication-related adverse effects, and mental health conditions, including depression and anxiety.^1,2

Postmenopausal women are disproportionately affected, with age-related declines in estrogen and testosterone contributing to reduced libido and increasing vulnerability to comorbid conditions, such as depression, that further exacerbate symptoms.^2,3

How Is HSDD Treated?

HSDD is treatable and manageable with treatment such as sex therapy and some medications, although these are limited. Estrogen and/or progestogens have shown some efficacy for vaginal atrophy, increasing vaginal lubrication and reducing dyspareunia, but seem ineffective for improving sexual desire.^2,4

Flibanserin represents a new approach for treating HSDD, focusing on the changes in the brain that drive low libido. It is a once-daily oral pill that acts on neurotransmitters in the brain related to sexual excitement. When these chemicals are out of balance, the result is a decreased level of sexual interest and desire. Flibanserin received its first FDA approval in 2015 for premenopausal women, which I now expanded for postmenopausal women under the age of 65.¹

"Menopause does not mark the end of a woman's sexuality, but for too long, medicine has treated it that way," said Mary Claire Haver, MD, OB-GYN and leading menopause expert. "This FDA approval is a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire. Expanding [flibanserin’s] approval is historic in validating women's experiences and ensuring that millions of women suffering have real choices when it comes to their sexual health."¹

REFERENCES

1. Historic First in Women's Sexual Health: FDA Grants Approval for Addyi® (flibanserin) in Postmenopausal Women. PR Newswire. December 15, 2025. Accessed December 15, 2205. https://www.prnewswire.com/news-releases/historic-first-in-womens-sexual-health-fda-grants-approval-for-addyi-flibanserin-in-postmenopausal-women-302642397.html

2. Hypoactive Sexual Desire Disorder (HSDD). American Sexual Health Association. Accessed December 15, 2025. https://www.ashasexualhealth.org/hypoactive-sexual-desire-disorder/

3. Low sex drive — could it be a sign of depression? John Hopkins Medicine. Accessed December 15, 2025. https://www.hopkinsmedicine.org/health/wellness-and-prevention/low-sex-drive-could-it-be-a-sign-of-depression#:~:text=Keep%20doing%20it.,the%20end%20of%20the%20tunnel.

4. Nappi RE, Wawra K, Schmitt S. Hypoactive sexual desire disorder in postmenopausal women. Gynecol Endocrinol. June 2006. doi: 10.1080/09513590600762265