FDA Broadens Addyi Approval to Postmenopausal Women Up to 65

The Food and Drug Administration announced on Monday that the once-a-day libido‑boosting pill Addyi can now be prescribed to postmenopausal women up to 65 years old, expanding the drug’s reach beyond its original premenopausal patient group.

FDA Expands Addyi Approval

The agency’s update broadens the drug’s use to older women who have gone through menopause. Addyi was first approved a decade ago for premenopausal women who report emotional stress due to low sex drive, and the new guidance allows clinicians to consider it for a wider age range.

Side Effects and Safety Warnings

Addyi, marketed by Sprout Pharmaceuticals, has been associated with dizziness and nausea. The drug carries a boxed warning about the dangers of combining it with alcohol, noting that drinking while taking the pill can cause dangerously low blood pressure and fainting. The label recommends waiting a few hours after several drinks before taking the drug, or skipping a dose.

Market Performance

Sales of Addyi have fallen short of Wall Street’s initial expectations. In 2019, the FDA approved a second drug for low female libido, an on‑demand injection that acts on a different set of neurological chemicals. The injection offers an alternative pathway for patients who did not respond to Addyi or who prefer a different delivery method.

Sprout’s Perspective

Sprout CEO Cindy Eckert said in a statement the approval “reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.” The company, based in Raleigh, North Carolina, announced the FDA update in a press release Monday.

The Condition

The medical condition for a troublingly low sexual appetite, called hypoactive sexual desire disorder, has been recognized since the 1990s and is thought to affect a significant portion of American women, according to surveys. After the blockbuster success of Viagra for men in the 1990s, drugmakers began pouring money into research and potential therapies for sexual dysfunction in women.

Diagnosis Challenges

Diagnosing hypoactive sexual desire disorder is complicated because of the many factors that can affect libido, especially after menopause, when falling hormone levels trigger a number of biological changes and medical symptoms. Doctors are supposed to rule out a number of other issues, including relationship problems, medical conditions, depression and other mental disorders, before prescribing medication.

Controversy Over Medicalization

The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem. These critics contend that labeling the condition as a disorder may pathologize normal variations in sexual desire.

FDA’s Prior Rejections

The FDA rejected Addyi twice prior to its 2015 approval, citing the drug’s modest effectiveness and worrisome side effects. The approval came after a lobbying campaign by the company and its supporters, Even the Score, which framed the lack of options for female libido as a women’s rights issue.

Key Takeaways

• Addyi’s FDA approval now includes postmenopausal women up to 65 years old.
• Side effects include dizziness, nausea, and a boxed warning about alcohol interaction.
• The drug’s sales have not met initial market expectations.
• Sprout CEO Cindy Eckert highlighted a decade of effort to shift the focus of women’s sexual health.

The FDA’s decision marks a significant step for women seeking treatment for hypoactive sexual desire disorder, yet it also underscores ongoing debates about the medicalization of female libido and the safety profile of Addyi.

Closing Thoughts

While the expanded approval offers more options for postmenopausal women, clinicians will need to weigh the drug’s benefits against its side effects and the broader context of sexual health care. The move reflects both progress in addressing a historically under‑treated condition and the persistent challenges that remain in treating female sexual dysfunction.