🔗 Share this article FDA Approves Addyi, a Desire-Boosting Treatment for Women After Menopause Flibanserin, sometimes referred to as “the women's Viagra,” is now cleared for treatment to address low sex drive in females beyond reproductive age. The FDA expanded its approval of flibanserin, a oral medication to treat low libido in women, to encompass women after menopause up to age 65. This decision will provide new treatment options for older women, but experts caution that addressing HSDD requires a “comprehensive strategy.” This drug presents serious risks with alcohol that may lead to syncope, so avoiding alcoholic beverages is essential. The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to treat low libido in women to cover women after menopause up to 65 years old. Prior to the recent news, the pill, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in premenopausal females. This medication was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial review process. The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits. Today, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen. The chief executive of the pharmaceutical company of Addyi praised the FDA’s move to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on female sexual health. Additional specialists in female health were supportive for the decision. “I had few tools for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.” A clinical professor told reporters that the approval was “logical” given the available data. Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not substantial. Does it justify taking a drug daily and not seeing a major effect?” What is Addyi, the ‘Female Viagra’? Flibanserin, which is often called “female Viagra,” has little in common with the drug from which it draws its nickname. This medication was first created as an antidepressant but was found to be lacking during initial trials. However, researchers noted improvements in aspects of sexual function and shifted focus to the drug’s potential as a treatment for low libido. 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 serious safety warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks. 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 three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely. Assertions about the effects of combining the drug with drinking eventually led the maker to fund further research investigating the interaction. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had concerns. “These studies aren't very convincing to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a health research president stated. An OB-GYN speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women. “Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said. Another doctor echoed uncertainty about why the expanded indication was limited at age 65. “I don’t know if that has to do with the intricacies 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 simpler guidance because it may affect our clinical decisions,” he said. Treating Low Libido After Menopause Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a different group of females who may find help. “I believe it will benefit this demographic better as long as they have no other medical problems,” said an OB-GYN. But it is not a quick fix. In fact, the specialists interviewed all agreed that the women's sexual desire is influenced by many factors. So treating HSDD means engaging with everything from partnership issues to hormonal changes. Postmenopausal females navigate a broad range of symptoms that can affect sexual desire. Menopausal symptoms encompass: sudden feelings of heat lack of natural lubrication pain during intercourse insomnia bladder leakage According to one expert, treating these issues is often a first step toward sexual wellness. “If somebody came to me 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 effects of menopause, particularly vaginal dryness. She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a viable choice. Testosterone is also occasionally used without formal approval to treat 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 would have no problem recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said. Additional suggestions for increasing sexual desire are: improving sleep hygiene engaging in physical activity staying active applying over-the-counter lubricants practicing extended intimate stimulation using vibrators or vaginal dilators “You have to take an entire whole body approach to sexuality and this life stage in older age,” said an OB-GYN. “That means understanding 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 sexual pleasure.”