🔗 Share this article FDA Approves Addyi, a Libido-Enhancing Medication for Females Beyond Menopause Flibanserin, often called “the women's Viagra,” is now approved for use to treat diminished libido in females beyond reproductive age. Regulators broadened the indication of Addyi, a pill to treat hypoactive sexual desire disorder (HSDD) in women, to include women after menopause up to age 65. This decision will provide additional therapeutic avenues for this demographic, but health professionals advise that addressing HSDD requires a “holistic method.” The medication carries potentially dangerous interactions with drinking that may cause loss of consciousness, so avoiding alcoholic beverages is strongly advised. The Food and Drug Administration (FDA) widened the indication of a oral treatment to manage low libido in women to include postmenopausal women up to age 65. Before the recent news, the medication, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females. Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process. Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile. Currently, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen. The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s move to expand the drug’s approval, calling it a “milestone” in advancing and focusing on female sexual health. Other specialists in female health were supportive for the regulatory move. “Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.” A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the existing research. While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?” Understanding Flibanserin, the ‘Female Viagra’? Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it gets its informal name. The drug was initially researched as an medication for depression but was found to be lacking during early studies. Nevertheless, scientists observed positive changes in aspects of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire. After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major lobbying effort. The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks. Official guidance advises allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person has several drinks on a given day, the instructions recommends skipping the dose entirely. Assertions about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the combination. The research, which were limited in size, showed no increased danger of syncope. But medical professionals had concerns. “This research aren't very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated. An gynecologist 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 dizziness 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 susceptible to effects like that,” she said. Another doctor echoed uncertainty about why the broader approval was limited at age 65. “It's unclear if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said. Treating Low Libido in Postmenopausal Women Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a different group of women who may find help. “I do think it will serve this population better as long as they have no other health issues,” said an OB-GYN. But it is not a simple solution. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors. So addressing low desire means engaging with everything from relationship dynamics to shifts in hormone levels. Women after menopause navigate a broad range of symptoms that can affect libido. Symptoms of menopause encompass: hot flashes vaginal dryness discomfort with sex insomnia bladder leakage As noted by one expert, managing these issues is often a initial approach toward sexual wellness. “When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said. The expert suggested both vaginal estrogen and systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness. She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option. Testosterone is also sometimes prescribed off-label to treat reduced desire in females, although it is not officially approved for it. But besides medication, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy. “I would have no problem recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said. Other suggestions for boosting libido include: improving sleep hygiene engaging in physical activity maintaining an active lifestyle using over-the-counter personal lubricants engaging in extended intimate stimulation using sexual wellness devices or vaginal dilators “You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “That means understanding 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.”