🔗 Share this article U.S. Food and Drug Administration Clears Addyi, a Desire-Boosting Medication for Women After Menopause Addyi, sometimes referred to as “female Viagra,” is now cleared for treatment to treat reduced sexual desire in women after menopause. The FDA expanded its approval of flibanserin, a oral medication to treat hypoactive sexual desire disorder (HSDD) in women, to include women after menopause up to age 65. This decision will open up additional therapeutic avenues for this demographic, but experts caution that addressing HSDD requires a “whole body approach.” Addyi is known to have potentially dangerous interactions with drinking that may lead to syncope, so avoiding alcoholic beverages is recommended. The Food and Drug Administration (FDA) widened the indication of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to age 65. Prior to the announcement, the pill, Addyi (flibanserin), was solely authorized to address low sexual desire in women of reproductive age. Flibanserin was first approved by the FDA in two thousand fifteen, following a protracted and controversial review process. The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile. Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen. The chief executive of the maker of flibanserin applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness. Other OB-GYNs expressed support for the decision. “I had few tools for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.” A clinical professor told reporters that the decision was “logical” given the available data. While in favor, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?” What is Addyi, the ‘Female Viagra’? Flibanserin, which is often called “female Viagra,” has significant differences with the medication from which it draws its nickname. This medication was originally developed as an antidepressant but was deemed ineffective during early studies. However, researchers observed improvements in aspects of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire. After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort. Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol. Official guidance recommends allowing a two-hour gap after drinking before using the drug to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely. Claims about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research examining the combination. The research, which were limited in size, showed no additional risk of fainting. But medical professionals had concerns. “These studies don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated. An gynecologist suggested that this may have been part of the reason why the drug was not originally approved for postmenopausal women. “Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said. Another doctor echoed confusion about why the broader approval was limited at 65 years of age. “I don’t know if that has to do with the intricacies of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said. Addressing Diminished Sexual Desire After Menopause Despite these risks, flibanserin could still expand therapeutic choices for low desire to a different group of females who may find help. “I do think it will serve this population better as long as they have no other medical problems,” said an OB-GYN. But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors. So addressing HSDD means engaging with everything from partnership issues to hormonal changes. Postmenopausal females navigate a wide variety of changes that can impact libido. Symptoms of menopause encompass: sudden feelings of heat lack of natural lubrication pain during intercourse insomnia bladder leakage As noted by one expert, treating these symptoms is often a first step toward sexual wellness. “If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said. The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly vaginal dryness. She hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice. Androgen therapy is also sometimes prescribed off-label to treat reduced desire in women, although it is not indicated for it. But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on relationships and intimacy. “I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said. Additional recommendations for boosting libido include: improving sleep hygiene engaging in physical activity maintaining an active lifestyle using over-the-counter personal lubricants practicing extended foreplay using vibrators or vaginal dilators “You have to take an entire whole body approach to sexual health and menopause in older age,” said an expert. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”