A Historic Win for Postmenopausal Women: FDA Expands Approval for HSDD

In 2015, the FDA approved Addyi® (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. Now, ten years later, the FDA has expanded this approval to include postmenopausal women up to age 65, representing a significant shift toward health equity.

What is HSDD?

Hypoactive Sexual Desire Disorder (HSDD) is a persistent lack of sexual interest or desire that causes personal distress. It is the most common form of sexual dysfunction in women, impacting an estimated 40% of the population.

Addyi is a prescription medicine used to treat HSDD in women up to age 65 without a history of low libido who experience low desire unrelated to another medical condition, mental health issues, medications, or relationship problems.

Why This Matters

HSDD is a common yet profoundly undertreated condition. For postmenopausal women, the historical lack of FDA-approved options has often led to the misconception that low desire is simply an inevitable part of aging.

• Science Over Stigma:

   This approval validates that sexual desire is rooted in biology and chemistry, not just “mood.”

• Equitable Care:

   It ensures women have access to evidence-based treatments at every stage of life, moving beyond just the reproductive years.

• Priority Status:

   The FDA granted “priority review” to the application, signaling that women’s sexual health is a “serious unmet medical need.”

Addyi Facts

Addyi is supported by large clinical trials with women reporting:

• Less distress about low desire
• Mild improvements in their sexual events
• 40-60% benefited within 4 weeks

Common side effects: 

• Sleepiness – *counter by taking the medication in the evening
• Nausea, fatigue, insomnia, and dry mouth that usually improves over time
• Severe low blood pressure, if combined with alcohol

The Bottom Line

Addyi is now the first and only FDA-approved treatment for women up to age 65. This is a victory for science, for choice, and for the millions of women who have been waiting for their quality of life to be prioritized.

Disclaimer: This article is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or prescription medication. Addyi® is a prescription medicine; please consult a healthcare professional to discuss its risks, benefits, and side effects.