The U.S. Food and Drug Administration (FDA) has approved the first daily pill specifically designed to treat low sexual desire in women who have gone through menopause. This landmark decision offers a new treatment option for a condition previously underserved by medical advancements.

The medication, known as Addyi (flibanserin), has received clearance to address hypoactive sexual desire disorder (HSDD) in postmenopausal women under the age of 65. This marks an expansion of its previous approval, which was granted a decade ago for premenopausal women experiencing the same condition.

Experts emphasize the significance of this development, calling it an “important milestone” for women’s sexual health. For the first time, a formally recognized FDA-approved treatment is available for women experiencing distress due to low libido after menopause, acknowledging a long-overlooked aspect of women’s well-being.

Addyi functions as a nonhormonal pill that influences brain chemicals, specifically neurotransmitters, which play a crucial role in sexual response pathways. The drug aims to enhance sexual desire by modulating levels of dopamine and norepinephrine while reducing serotonin, thereby facilitating the brain’s natural sexual signaling.

While hormonal changes like the decline of estrogen and progesterone are associated with menopause, they are not definitively linked to a reduction in sex drive. Other menopause symptoms, such as pain during intercourse or vaginal dryness, can also impact libido, and hormonal therapies may address these specific issues.

Clinical trials demonstrated positive results, with postmenopausal women taking Addyi reporting a significant increase in sexual desire and a greater number of satisfying sexual encounters compared to those taking a placebo. These improvements were comparable to those observed in trials with premenopausal women.

However, Addyi carries a black box warning due to the risk of dangerously low blood pressure and fainting. This risk is amplified for individuals with certain liver conditions, those who consume alcohol close to bedtime, or those taking specific medications. Strict guidelines regarding alcohol consumption are in place to mitigate these dangers.

Physicians’ willingness to address low libido in older women has been a historical barrier, partly due to the lack of approved treatments. Many healthcare providers may also lack specialized training in managing women’s sexual health during and after menopause.

Despite the potential benefits, the cost of Addyi remains a significant concern for many postmenopausal women. Without insurance, the medication can range from hundreds to over a thousand dollars per month, although discounts and insurance coverage may reduce this burden.

The FDA’s decision to extend Addyi’s approval to women up to age 65 is viewed as a pivotal moment. It signals a greater prioritization of sexual health for postmenopausal women, offering a much-needed treatment for a common and often undertreated condition.

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Keywords: low sex drive, postmenopausal women, FDA approval, Addyi, flibanserin, hypoactive sexual desire disorder, HSDD, women's sexual health