🔗 Share this article FDA Clears Flibanserin, a Desire-Boosting Treatment for Postmenopausal Flibanserin, sometimes referred to as “female Viagra,” is now approved for use to combat diminished libido in females beyond reproductive age. Regulators broadened the indication of Addyi, a oral medication to address low libido in women, to include women after menopause up to age 65. The approval will unlock fresh choices for this demographic, but health professionals advise that addressing HSDD requires a “whole body approach.” This drug presents potentially dangerous interactions with alcohol that may lead to loss of consciousness, so abstinence from alcohol is strongly advised. U.S. regulators widened the indication of a oral treatment to treat low libido in women to cover postmenopausal women up to 65 years old. Prior to the announcement, the medication, Addyi (flibanserin), was only approved to address low sexual desire in premenopausal females. This medication was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period. The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile. Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019. The chief executive of the maker of flibanserin praised the FDA’s action to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness. Other specialists in female health voiced approval for the decision. “There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be very important to help postmenopausal women 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 decision was “quite reasonable” given the available data. Although supportive, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?” Understanding Addyi, the ‘Female Viagra’? Flibanserin, which is often called “the women's version of Viagra,” has little in common with the drug from which it draws its nickname. This medication was initially researched as an medication for depression but was deemed ineffective during initial trials. Nevertheless, scientists observed improvements in measures of sexual function and shifted focus to the drug’s possible use as a therapy for low libido. After two rejections, flibanserin was approved in 2015 to treat HSDD, following additional research and a major advocacy campaign. Addyi carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol. Official guidance advises waiting at least two hours after drinking before using Addyi to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely. Assertions about the interactions of mixing the drug with drinking eventually prompted the maker to fund additional studies examining the combination. The research, which were limited in size, showed no increased danger of syncope. But experts had concerns. “These studies don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated. An gynecologist speculated that this may have been part of the reason why the drug was not initially cleared for older females. “Patients have experienced side effects like the syncopal episodes 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 things like that,” she said. Another doctor echoed confusion about why the expanded indication was capped at age 65. “I don’t know if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said. Treating Low Libido After Menopause Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a new population of women who may benefit. “I believe it will serve this population better as long as they have no other medical problems,” said an OB-GYN. But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the female libido is complex and multifaceted. So treating HSDD means considering everything from partnership issues to shifts in hormone levels. Postmenopausal females experience a broad range of symptoms that can affect libido. Menopausal symptoms encompass: sudden feelings of heat lack of natural lubrication discomfort with sex sleep disturbances bladder leakage According to one expert, treating these symptoms is often a first step toward sexual wellness. “When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said. The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly dryness. She hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a treatment option. Testosterone is also sometimes used without formal approval to treat reduced desire in females, although it is not indicated for it. But besides medication, experts say that lifestyle should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy. “I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said. Other suggestions for boosting libido include: getting more sleep engaging in physical activity maintaining an active lifestyle applying over-the-counter lubricants engaging in extended foreplay incorporating vibrators or vaginal dilators “It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “That means knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”