🔗 Share this article FDA Approves Addyi, a Desire-Boosting Drug for Postmenopausal Flibanserin, often called “the women's Viagra,” is now approved for use to treat diminished libido in women after menopause. Regulators broadened the indication of flibanserin, a pill to address hypoactive sexual desire disorder (HSDD) in women, to encompass women after menopause up to age 65. The approval will unlock additional therapeutic avenues for this demographic, but health professionals advise that addressing HSDD requires a “holistic method.” Addyi is known to have potentially dangerous interactions with alcohol that may result in syncope, so avoiding alcoholic beverages is essential. U.S. regulators expanded its approval of a once-a-day medication to address low libido in females to cover postmenopausal women up to age 65. Prior to the recent news, the medication, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in premenopausal females. Flibanserin was originally authorized by the FDA in 2015, following a lengthy and contentious regulatory scrutiny. Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits. Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen. The founder and CEO of the maker of Addyi praised the FDA’s move to expand the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness. Other women’s health experts expressed support for the decision. “Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be crucial to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.” A clinical professor told reporters that the decision was “logical” given the available data. Although supportive, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?” What is Flibanserin, the ‘Women's Desire Pill’? Addyi, which is often called “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname. The drug was originally developed as an medication for depression but was deemed ineffective during early studies. However, scientists noted positive changes in aspects of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire. Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort. The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol. The label recommends waiting at least two hours after drinking before using Addyi to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely. Claims about the interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns. “This research don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a health research president stated. An OB-GYN speculated that this may have been part of the cause why the drug was not originally approved for postmenopausal women. “Patients have experienced side effects like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said. Another doctor expressed confusion about why the expanded indication was limited at 65 years of age. “It's unclear if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. 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 in Postmenopausal Women Notwithstanding the warnings, Addyi could still broaden therapeutic choices for HSDD to a different group of women who may find help. “I believe it will serve this population better as long as they have no other health issues,” said an specialist. But it is not a magic bullet. In fact, the experts consulted all agreed that the female libido is complex and multifaceted. So addressing low desire means engaging with everything from partnership issues to shifts in hormone levels. Women after menopause navigate a broad range of symptoms that can affect sexual desire. Menopausal symptoms encompass: hot flashes lack of natural lubrication discomfort with sex sleep disturbances bladder leakage According to one expert, managing these issues is often a first step toward improved intimacy. “When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said. The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly vaginal dryness. She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a treatment option. Testosterone is also occasionally prescribed off-label to address low libido in females, although it is not officially approved for it. But besides medication, experts say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy. “I am comfortable recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said. Additional suggestions for increasing libido are: improving sleep hygiene exercising maintaining an active lifestyle applying over-the-counter lubricants engaging in extended intimate stimulation incorporating sexual wellness devices or dilators “It requires an entire whole body approach to sexual health and this life stage in older age,” said an expert. “This involves knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”