The U.S. Food and Drug Administration said overnight Tuesday that it has expanded approval for the use of Addyi, a daily pill designed to boost sexual desire in women, allowing it to be prescribed to women over 65 who have gone through menopause. The drug, which previously sparked controversy among researchers over its effectiveness, is not yet available for use in Israel.
Addyi, marketed by Sprout Pharmaceuticals, was first approved in 2015 for premenopausal women who reported emotional distress linked to low sexual desire. Now, a decade later, the FDA has cleared its use for older women as well. The company announced the decision in a press release issued Monday.
Dr. Israel Yoles, director of Clalit Health Services’ online menopause medicine service and head of Clalit’s Women’s Health Center in Modi’in Illit, urged caution. Clalit is Israel’s largest health maintenance organization. “Drug treatment for sexuality during menopause is complex, and unlike treatment for symptoms such as hot flashes or sleep disturbances, which is relatively more straightforward, it is subject to disagreement even within the scientific community,” he said.
Dr. Israel YolesPhoto: CourtesyAccording to Yoles, the key questions center on the causes of reduced sexual desire: whether it stems from routine and burnout, emotional factors or mood issues, or from a process directly linked to menopause itself. “In situations where the biological component is more significant than the environmental one, there may be a therapeutic role for a drug of this kind,” he said.
As noted, the drug is not currently available in Israel. Its outcomes will need to be evaluated to determine whether its therapeutic promise is ultimately fulfilled.
Side effects and a serious warning
Addyi was initially intended to become a widely used drug and to fill a significant niche in women’s health. In practice, its use has remained limited, in part because of side effects such as dizziness and nausea, as well as a serious safety warning regarding the combination of the drug with alcohol. The medication carries a boxed warning — the FDA’s most severe level — stating that drinking alcohol while taking it may cause a dangerous drop in blood pressure and even fainting.
The drug works on brain chemicals linked to mood and appetite. In 2019, the FDA approved another treatment for low sexual desire in women, an injection taken as needed that acts on a different set of neurological chemicals.
Sprout Pharmaceuticals CEO Cindy Eckert said in a statement that the expanded approval “reflects a decade of tireless work with the FDA to fundamentally change the way women’s sexual health is understood and prioritized,” according to ABC News.
The medical condition the drug is intended to treat, known as hypoactive sexual desire disorder, has been recognized since the 1990s and, according to surveys, affects a significant share of women in the United States. After the major success of Viagra for men in the 1990s, pharmaceutical companies began investing heavily in the development of treatments for sexual dysfunction in women.
Diagnosing the disorder, however, is complex. Many factors can affect sexual desire, particularly after menopause, when declining hormone levels lead to biological changes and a range of medical symptoms. Before prescribing the drug, physicians are required to rule out other causes, including relationship problems, medical conditions, depression and other mental health disorders. The diagnosis itself is not universally accepted, and some psychologists argue that reduced sexual desire should not be considered a medical condition.
Menopause and declining sexual desire
Dr. Yoles explains that against the backdrop of a wide range of changes, some hormonal and others environmental or social, a general decline in sexuality is commonly seen around menopause. “In recent years there has been a significant awakening around menopause, a process that has existed in medicine for about 15 years and continues to expand in research and treatment, as well as in awareness among physicians, the public and women themselves,” he said.
According to Yoles, menopause is no longer viewed as a single symptom but as a life stage that affects many areas and is gradually receiving the attention it deserves. “In practice, nearly half of a woman’s life is accompanied by menopausal symptoms. These changes typically begin around ages 45 to 47 and are characterized by a range of well-known symptoms resulting from estrogen deficiency,” he said.
These include sleep disturbances, sweating and hot flashes, heart palpitations, reduced concentration, difficulty recalling words and ideas, and a decline in sexual desire. In addition to falling estrogen levels, levels of active testosterone in the body also decline. Yoles said the hormone is known to have a significant impact on sexuality and libido, and in some cases menopausal women are treated with testosterone to improve this aspect of their lives.
Addyi, which has recently come under renewed discussion, does not work through testosterone but through a different mechanism linked to the serotonin system. The FDA rejected approval of Addyi twice before granting it clearance in 2015, citing limited effectiveness and concerning side effects. Approval came after a lobbying campaign led by the company and its supporters under the banner “Even the Score,” which framed the lack of treatments for female sexual desire as a women’s rights issue.