Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration (FDA) has expanded the approval of Addyi (flibanserin) to include postmenopausal women diagnosed with hypoactive sexual desire disorder (HSDD). This regulatory update marks an important step toward addressing an often-overlooked women’s health condition that affects quality of life, emotional well-being, and intimate relationships in midlife and beyond.
With this decision, Addyi becomes the first FDA-approved oral treatment for acquired, generalized HSDD in both premenopausal and postmenopausal women, expanding access to a therapy that targets the neurobiological basis of sexual desire rather than hormonal pathways.
Cindy Eckert, Founder and Chief Executive Officer, Sprout Pharmaceuticals, said the approval reflects more than a decade of work with the FDA to elevate women’s sexual health through science. She noted that the decision recognizes the need for equitable, evidence-based care for women at every stage of life.
Hypoactive Sexual Desire Disorder (HSDD)
HSDD is a clinically recognized condition characterized by:
- Persistently low or absent sexual desire
- Personal distress related to reduced libido
- Symptoms not explained by medical illness, medications, or relationship issues
HSDD is common among postmenopausal women, where physiological aging, neurochemical changes, and psychosocial factors often intersect. Despite its prevalence, treatment options have historically been limited, particularly for women who cannot or do not wish to use hormone-based therapies.
What Is Addyi (Flibanserin)?
Addyi (flibanserin) is a centrally acting, non-hormonal medication taken once daily at bedtime. Unlike drugs that work on blood flow or hormones, Addyi targets brain neurotransmitters involved in sexual desire.
Flibanserin works by
Increasing dopamine and norepinephrine activity, which are linked to sexual excitement
Reducing serotonin activity, which can suppress sexual desire
This neurochemical rebalancing helps restore sexual interest in women with HSDD.
Expansion to Postmenopausal
The initial FDA approval of Addyi was limited to premenopausal women, leaving a significant gap for postmenopausal patients experiencing similar distressing symptoms.
The expanded approval was supported by clinical trial data showing that postmenopausal women experienced meaningful improvements in sexual desire, reduced distress, and increased satisfying sexual events compared with placebo.
This decision recognizes that:
- HSDD is not limited to the reproductive age
- Sexual health remains important throughout a woman’s lifespan
- Non-hormonal treatment options are needed in postmenopausal
Clinical Evidence
In randomized, placebo-controlled studies involving postmenopausal women with HSDD, Addyi demonstrated:
- Statistically significant improvements in sexual desire scores
- Reduction in distress related to low libido
- Favorable benefit-risk balance when used as directed
While the degree of improvement varies between individuals, the FDA concluded that the benefits outweighed the risks for appropriately selected patients.
Safety
Addyi carries a boxed warning and must be prescribed with careful counselling.
Key Safety Points
- Alcohol use is contraindicated due to the risk of severe hypotension and syncope
- Common side effects include dizziness, sleepiness, nausea, fatigue, and dry mouth
- Should not be used with certain CYP3A4 inhibitors
- Taken only at bedtime to reduce the risk of low blood pressure and fainting
Healthcare providers are required to assess patient suitability and provide clear guidance on safe use.
Who May Benefit from Addyi?
Addyi may be considered for postmenopausal women who:
- Have acquired, generalized HSDD
- Experience personal distress due to low sexual desire
- Do not have libido issues caused by medications, depression, or relationship factors
- Prefer a non-hormonal treatment option
It is not intended for women whose low desire is situational or related to another medical condition.
A Broader Shift in Women’s Sexual Health
Dr. Rachel Rubin, Urologist and Sexual Medicine Specialist, said the expanded approval finally offers postmenopausal women an FDA-approved option for low sexual desire. She emphasized that the decision validates patients’ quality of life and acknowledges sexual health as a meaningful component of overall well-being.
Dr. Mary Claire Haver, Obstetrician-Gynecologist and Menopause Specialist, said the approval challenges the long-standing notion that menopause ends a woman’s sexuality. She added that expanding Addyi’s indication provides long-overdue, evidence-based choices for postmenopausal women experiencing low sexual desire.
The FDA’s decision reflects a broader recognition that female sexual dysfunction is a legitimate medical condition deserving evidence-based treatment. By extending Addyi’s indication, regulators have acknowledged the unmet needs of postmenopausal women who have long had limited therapeutic choices.
This approval also reinforces the importance of open conversations between patients and healthcare providers about sexual health, aging, and quality of life.
References
Historic First in Women’s Sexual Health: FDA Grants Approval for Addyi® (flibanserin) in Postmenopausal Women, PR Newswire, 15 December 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) tablets, Highlights of Prescribing Information, https://addyi.com/pi/
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women, ClinicalTrials.gov ID NCT00996372, https://clinicaltrials.gov/study/NCT00996372
Simon JA et al, Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014 Jun;21(6):633-40. doi: 10.1097/GME.0000000000000134. PMID: 24281236.