FDA Expands Libido Drug Addyi for Postmenopausal Women Up to Age 65

Breakthrough Approval After Decade of Advocacy

The Food and Drug Administration has taken a historic step in women's healthcare by expanding approval of Addyi, the controversial "little pink pill," to include postmenopausal women up to age 65. The announcement Monday from the Food and Drug Administration broadens the drug's use to older women who have gone through menopause. This marks the first FDA-approved treatment specifically targeting low libido in postmenopausal women, addressing what experts call a long-overlooked medical need.

The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive. The expanded approval comes after what Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, called "a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized." The company received Priority Review designation from the FDA earlier this year, expediting the approval process.

The data used for this new FDA approval for post-menopausal women is the same data Addyi submitted in 2015, with participants ages 18-80 included in the clinical trial. In a meta-analysis of randomized controlled trials from 2015 to 2024, the medication outperformed placebo in improving participants' sexual desire score, and most , more premenopausal and postmenopausal women with HSDD reported a "meaningful benefit" from Addyi than those who received a placebo.

Addressing a Common but Complex 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. An estimated one in 10 women have HSDD, which makes it one of the most common female sexual health complaints. The condition becomes particularly relevant during menopause, when hormonal changes create additional challenges.

Low libido affects approximately 40% - 55% of women during menopause, caused by falling levels of estrogen, progesterone and testosterone. Hormonal changes can also cause vaginal dryness and emotional shifts and fatigue, all of which can impact desire. The decline in testosterone over menopause is rarely addressed, and the use of Addyi can help with restoring sexual desire, and improving libido for women as they enter into the postmenopausal years, outside of the use of hormone replacement therapy.

Addyi helps balance neurotransmitters like dopamine, serotonin, and norepinephrine to support sexual desire, though the exact mechanism of action of Addyi is unknown. Unlike Viagra, which addresses physical dysfunction, Addyi targets the brain chemistry involved in sexual desire.

Safety Concerns and Side Effects Remain

Despite its breakthrough status, Addyi carries significant safety warnings that patients must consider carefully. The drug came with unpleasant side effects including dizziness and nausea, and it carries a safety warning about the dangers of combining it with alcohol. The boxed warning cautions that drinking while consuming the pill can cause dangerously low blood pressure and fainting.

Adverse reactions occurred in at least 2% of patients; the most common were dizziness, somnolence, nausea, fatigue, insomnia and dry mouth. Patients should take Addyi at bedtime and avoid excessive alcohol to prevent severe hypotension and syncope. The FDA's boxed warning represents the agency's most serious type of safety alert.

Sales of Addyi, which acts on brain chemicals that affect mood and appetite, fell short of Wall Street's initial expectations. The drug's commercial performance has been hampered by both its side effects and the complexity of treating female sexual dysfunction compared to male erectile dysfunction medications.

Changing the Landscape of Women's Sexual Health

This approval represents a significant shift in how medicine approaches women's sexuality and aging. As Dr. Mary Claire Haver, an OB-GYN and leading menopause expert, noted: "Menopause does not mark the end of a woman's sexuality but for too long, medicine has treated it that way. This FDA approval is a long-overdue recognition that postmenopausal women deserve evidence-based treatment options for low sexual desire."

There are plenty of options for men to use for low libido, while Addyi is one of the few FDA-approved medications for women. It is very important that we allow women to feel empowered in their sexual health and intimacy. The approval addresses a disparity that has existed since Viagra's introduction in the 1990s, when pharmaceutical companies began investing heavily in sexual dysfunction research but struggled to develop effective treatments for women.

While Addyi won't work for everyone and libido remains a multifaceted issue influenced by psychological, relationship, and physical factors, this expanded approval provides postmenopausal women with their first FDA-approved pharmaceutical option for addressing low sexual desire. As healthcare continues to evolve, this decision signals a growing recognition that women's sexual health deserves the same attention