🔗 Share this article U.S. Food and Drug Administration Clears Flibanserin, a Desire-Boosting Treatment for Postmenopausal Flibanserin, often called “the women's Viagra,” is now cleared for treatment to address reduced sexual desire in women after menopause. The agency widened the authorized use of flibanserin, a daily drug to address low libido in women, to include women after menopause up to age 65. The approval will open up additional therapeutic avenues for older women, but experts caution that addressing HSDD requires a “holistic method.” The medication carries potentially dangerous interactions with drinking that may result in fainting, so avoiding alcoholic beverages is strongly advised. U.S. regulators expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to 65 years old. Before this week's decision, the drug, Addyi (flibanserin), was solely authorized to treat low sexual desire in women of reproductive age. This medication was originally authorized by the FDA in 2015, following a protracted and controversial evaluation period. The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the agency cited issues about safety, efficacy, and an unfavorable risk–benefit profile. Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen. The chief executive of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness. Additional specialists in female health were supportive for the regulatory move. “Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.” A clinical professor told reporters that the approval was “understandable” given the existing research. Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?” What is Flibanserin, the ‘Women's Desire Pill’? Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it gets its informal name. This medication was first created as an antidepressant but was found to be lacking during initial trials. Nevertheless, researchers noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire. After two rejections, Addyi was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort. The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol. Official guidance advises waiting at least two hours after consuming alcohol before taking the drug to minimize the chance of syncope. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely. Assertions about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the interaction. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had concerns. “This research aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated. An gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women. “There have been adverse reactions like the fainting spells and dizziness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said. Another doctor expressed uncertainty about why the broader approval was capped 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 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 After Menopause Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD to a new population of women who may benefit. “I believe it will benefit this population better as long as they have no other health issues,” said an OB-GYN. But it is not a quick fix. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors. So treating low desire means engaging with everything from relationship dynamics to hormonal changes. Postmenopausal females navigate a wide variety of symptoms that can impact sexual desire. Menopausal symptoms include: hot flashes vaginal dryness pain during intercourse insomnia urinary incontinence 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 suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly vaginal dryness. She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less concerned about it and to consider it as a treatment option. Androgen therapy is also sometimes used without formal approval to treat low libido in females, although it is not indicated for it. But besides medication, doctors say that personal habits should also be considered. Conversations about sexual desire almost always start with relationships and intimacy. “I would have no problem recommending Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said. Other recommendations for increasing libido are: getting more sleep engaging in physical activity maintaining an active lifestyle applying over-the-counter lubricants engaging in extended foreplay incorporating sexual wellness devices 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 knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”