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FDA Approves Addyi for Women Up to 65, Boosting Libido Access

FDA Approves Addyi for Women Up to 65, Boosting Libido Access
Editorial
  • PublishedDecember 23, 2025

UPDATE: The FDA has just announced an expansion of its approval for the libido-boosting pill, Addyi, now allowing use for women up to 65 years old who are postmenopausal. This significant decision, made public on December 16, 2023, marks a pivotal moment in addressing female sexual health issues, particularly for those experiencing hypoactive sexual desire disorder.

This once-a-day pill, originally approved in 2015 for premenopausal women, has been a controversial treatment option. It targets emotional stress linked to low sex drive, a condition affecting a large number of American women. According to surveys, this medical condition can impact many, especially after menopause, when hormonal changes can lead to decreased libido.

The FDA approval comes with critical warnings. Addyi is known to have side effects like dizziness and nausea. Additionally, it carries a serious warning against alcohol consumption, which can lead to dangerously low blood pressure and fainting. Patients are advised to avoid drinking alcohol or to wait several hours after consuming alcohol before taking the medication.

Sprout Pharmaceuticals, the manufacturer based in Raleigh, N.C., is hopeful that this approval will help change perceptions around women’s sexual health. CEO Cindy Eckert stated, “This reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.”

Despite the initial enthusiasm surrounding Addyi, sales have not met expectations. The drug was anticipated to become a blockbuster treatment but has struggled in the market due to its side effects and strict consumption guidelines. In 2019, the FDA approved another drug aimed at addressing low female libido through an on-demand injection, further diversifying treatment options.

The condition known as hypoactive sexual desire disorder has been recognized since the 1990s, gaining more attention following the introduction of Viagra for men. However, diagnosing this condition can be complex. Health professionals must rule out other factors affecting libido, including relationship issues, medical conditions, and mental health disorders, before prescribing medications like Addyi.

The approval of Addyi for older women comes amid ongoing discussions about the medicalization of women’s sexual health issues. Some psychologists argue that low libido should not be classified as a medical problem. Nevertheless, the FDA’s recent decision underscores a growing recognition of women’s health needs in a field historically dominated by male-centric treatments.

Looking ahead, healthcare providers will need to navigate the challenges of prescribing Addyi while ensuring patients are informed about its risks and benefits. As more women gain access to this treatment, the conversation surrounding female libido and health is likely to evolve further.

This urgent development not only highlights the FDA’s commitment to expanding treatment options for women but also emphasizes the need for ongoing dialogue about women’s health issues. For those affected by low libido, this could mean a new avenue for relief and empowerment.

Stay tuned for more updates as this story develops and the impact of this approval unfolds in the coming weeks.

Editorial
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