🔗 Share this article U.S. Food and Drug Administration Clears Flibanserin, a Desire-Boosting Drug for Postmenopausal Addyi, sometimes referred to as “female Viagra,” is now approved for use to treat low sex drive in women after menopause. The agency widened the authorized use of Addyi, a daily drug to treat hypoactive sexual desire disorder (HSDD) in women, to encompass postmenopausal women up to age 65. This decision will unlock additional therapeutic avenues for this demographic, but experts caution that treating low libido requires a “comprehensive strategy.” This drug presents potentially dangerous interactions with alcohol that may lead to syncope, so abstinence from alcohol is essential. U.S. regulators broadened the authorized use of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to age 65. Before this week's decision, the medication, Addyi (flibanserin), was exclusively cleared to address 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 both cases, the FDA raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile. Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019. The chief executive of the maker of flibanserin commended the FDA’s move to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health. Additional OB-GYNs were supportive for the decision. “There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be significant to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.” A clinical professor told news outlets that the approval was “quite reasonable” given the existing research. While in favor, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not substantial. Does it justify taking a drug daily and not getting bang for your buck?” What is Addyi, the ‘Female Viagra’? Addyi, which is often called “female Viagra,” has few similarities with the medication from which it gets its informal name. The drug was first created as an antidepressant but was considered unsuccessful during initial trials. However, researchers observed positive changes in aspects of libido and arousal and redirected efforts 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 further studies and a major lobbying effort. Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcohol. The label recommends waiting at least two hours after drinking before taking the drug to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the label advises not taking the pill entirely. Assertions about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, showed no additional risk of syncope. But medical professionals had concerns. “These studies aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president stated. An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women. “There have been adverse reactions like the syncopal episodes and dizziness especially in persons 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 broader approval was limited at 65 years of age. “It's unclear if that has to do with the complexity 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 easier information sheet because it may affect our clinical decisions,” he said. Addressing Diminished Sexual Desire in Postmenopausal Women 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 health issues,” said an OB-GYN. But it is not a quick fix. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted. So treating HSDD means considering everything from relationship dynamics to hormonal changes. Postmenopausal females experience a broad range of changes that can affect sexual desire. Symptoms of menopause encompass: hot flashes vaginal dryness discomfort with sex sleep disturbances bladder leakage As noted by one expert, managing these symptoms is often a first step toward sexual wellness. “When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly vaginal dryness. She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less concerned about it and to view it as a viable choice. Androgen therapy 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 factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness. “I would have no problem recommending Addyi 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. Additional suggestions for increasing sexual desire include: getting more sleep engaging in physical activity staying active using over-the-counter personal lubricants engaging in extended intimate stimulation incorporating sexual wellness devices or vaginal dilators “It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”