🔗 Share this article FDA Approves Flibanserin, a Libido-Enhancing Medication for Females Beyond Menopause Addyi, sometimes referred to as “the women's Viagra,” is now cleared for treatment to address diminished libido in females beyond reproductive age. Regulators broadened the indication of Addyi, a oral medication to treat hypoactive sexual desire disorder (HSDD) in women, to encompass postmenopausal women up to age 65. The approval will unlock additional therapeutic avenues for this demographic, but health professionals advise that addressing HSDD requires a “whole body approach.” The medication carries potentially dangerous interactions with alcohol that may cause syncope, so avoiding alcoholic beverages is recommended. U.S. regulators expanded its approval of a once-a-day medication to manage low libido in women to now encompass postmenopausal women up to age 65. Prior to the announcement, the drug, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in women of reproductive age. This medication was originally authorized by the FDA in 2015, following a long and debated review process. The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile. Now, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019. The chief executive of the pharmaceutical company of flibanserin commended the FDA’s action to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health. Other specialists in female health expressed support for the regulatory move. “I had few tools for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.” A clinical professor told reporters that the decision was “understandable” given the available data. Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the benefit is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?” Understanding Addyi, the ‘Female Viagra’? Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname. The drug was initially researched as an antidepressant but was deemed ineffective during early studies. Nevertheless, scientists observed positive changes in aspects of libido and arousal 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 further studies and a major 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 recommends waiting at least two hours after drinking before using Addyi to reduce the risk of fainting. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely. Claims about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. 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 beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated. An OB-GYN suggested that this may have been part of the cause why Addyi was not originally approved for postmenopausal women. “Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said. Another doctor echoed confusion about why the expanded indication was limited at 65 years of age. “It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said. Treating Diminished Sexual Desire After Menopause Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a new population of females who may benefit. “I do think it will benefit this population better as long as they have no other health issues,” said an OB-GYN. But it is not a magic bullet. In fact, the specialists consulted all agreed that the female libido is complex and multifaceted. So treating 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 impact libido. Menopausal symptoms include: hot flashes lack of natural lubrication pain during intercourse insomnia bladder leakage As noted by one expert, managing these issues is often a first step toward improved intimacy. “When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly vaginal dryness. She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a treatment option. Androgen therapy is also occasionally prescribed off-label to address low libido in women, although it is not indicated for it. But besides medication, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always start with partnership dynamics and closeness. “I am comfortable prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said. Other recommendations for increasing libido include: improving sleep hygiene exercising maintaining an active lifestyle using over-the-counter lubricants practicing extended intimate stimulation incorporating sexual wellness devices or vaginal dilators “It requires an entire whole body approach to sexual health and this life stage in later life,” 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.”