The U.S. Food and Drug Administration (FDA) has approved the use of the drug Addyi for postmenopausal women with hypoactive sexual desire disorder (HSDD). This was reported to Women’s Health (WHealth) by Lauren Streicher, Professor of Obstetrics and Gynecology at the Feinberg School of Medicine at Northwestern University.

Addyi was developed to treat women with HSDD—a condition characterized by reduced or absent sexual desire that causes significant psychological distress. The active ingredient in the drug, flibanserin, affects the balance of neurotransmitters in the brain, in particular by reducing serotonin activity, which may help enhance libido.

The FDA initially approved Addyi in 2015, but only for premenopausal women. This stage is marked by gradual changes in hormonal balance, including declining levels of the female hormones estrogen and progesterone. The FDA has now expanded the indications, allowing the drug to be used after the onset of menopause, which typically occurs between the ages of 45 and 55.

The decision was based on data from successful clinical trials involving volunteers aged 18 to 80. The same data were also used for the drug’s initial approval.

According to a meta-analysis of randomized controlled trials conducted between 2015 and 2024, Addyi was more effective than placebo in improving measures of sexual desire. These outcomes were assessed using electronic diaries completed by participants. In addition, a greater number of women—both premenopausal and postmenopausal—reported “significant benefit” from the drug compared with those who received a placebo.

The expert emphasized that the medication does not work for everyone, as reduced libido can be linked to psychological, hormonal, and social factors. Nevertheless, she described the expanded approval as an important step, noting that men have several pharmacological treatment options for sexual disorders, while women have very few.