FDA Approves Addyi for Women Over 65, Expanding Access to Libido-Boosting Drug
U.S. health officials have expanded the approval of the libido-boosting drug Addyi, enabling women over the age of 65 who have gone through menopause to use this once-a-day pill. The announcement from the Food and Drug Administration (FDA) on March 25, 2025, marks a significant shift in the medication’s availability, which was initially approved a decade ago for premenopausal women experiencing emotional distress related to low sex drive.
This expansion allows older women facing hypoactive sexual desire disorder, a condition recognized since the 1990s, to access a treatment option that has been under scrutiny since its inception. According to surveys, this disorder is thought to affect a substantial number of American women, highlighting a persistent gap in women’s health treatments.
Addyi, produced by Sprout Pharmaceuticals, was expected to be a breakthrough in addressing female sexual health but has faced challenges. The drug is known to induce side effects such as dizziness and nausea, and it comes with a serious safety warning regarding alcohol consumption. A boxed warning from the FDA indicates that drinking while taking Addyi can lead to dangerously low blood pressure and fainting, raising concerns about its overall safety profile.
Despite these limitations, Sprout CEO Cindy Eckert expressed optimism about the recent approval. In a statement, she emphasized that this decision reflects years of collaboration with the FDA to enhance the understanding and prioritization of women’s sexual health.
The approval of Addyi followed a contentious history, including two rejections prior to its eventual approval in March 2015. The FDA originally cited the drug’s modest efficacy and concerning side effects as reasons for its initial denials. However, a concerted lobbying effort by Sprout and advocacy group Even the Score framed the lack of treatment options for female libido as a women’s rights issue, ultimately influencing the FDA’s decision.
As the landscape of women’s sexual health continues to evolve, it is essential to consider the complexities involved in diagnosing low libido. Factors that can affect sexual desire include hormonal changes post-menopause, relationship dynamics, and mental health conditions. Medical professionals are tasked with ruling out these variables before prescribing medication, a process that can complicate diagnosis and treatment.
In 2019, the FDA approved another treatment for low female libido, an on-demand injection targeting a different neurological pathway. This further indicates a growing recognition of the need for diverse options in addressing female sexual dysfunction.
The expansion of Addyi’s approval signifies not only a win for women seeking solutions for hypoactive sexual desire disorder but also highlights the ongoing dialogue about women’s health issues. As more attention is directed toward this area, the hope remains that additional treatments will emerge to support women in their sexual health journeys.
