🔗 Share this article FDA Clears Addyi, a Libido-Enhancing Treatment for Women After Menopause Flibanserin, often called “female Viagra,” is now approved for use to combat low sex drive in postmenopausal women. The FDA expanded its approval of Addyi, a daily drug to treat low libido in women, to encompass women after menopause up to age 65. The approval will open up additional therapeutic avenues for this demographic, but health professionals advise that addressing HSDD requires a “comprehensive strategy.” The medication carries potentially dangerous interactions with alcohol that may result in syncope, so avoiding alcoholic beverages is strongly advised. The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to treat low libido in women to now encompass women after menopause up to 65 years old. Before the announcement, the medication, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age. This medication was first approved by the FDA in 2015, following a long and debated review process. Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the agency raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile. Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen. The chief executive of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness. Additional women’s health experts voiced approval for the decision. “There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be very important to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.” A clinical professor told reporters that the approval 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 inactive pill, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?” What is Flibanserin, the ‘Female Viagra’? Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name. The drug was first created as an medication for depression but was deemed ineffective during early studies. However, researchers observed improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire. After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a major advocacy campaign. The medication carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks. The label recommends waiting at least two hours after consuming alcohol before taking Addyi to minimize the risk of syncope. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely. Claims about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the combination. The research, which were small in scale, showed no increased danger of fainting. But experts had concerns. “This research aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated. An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for older females. “Patients have experienced adverse reactions like the fainting spells 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 limited at age 65. “I don’t know if that has to do with the intricacies of the medication. 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 easier information sheet because it may affect our prescribing,” he said. Addressing Diminished Sexual Desire in Postmenopausal Women Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a new population of women who may find help. “I do think it will serve this population better as long as they have no other health issues,” said an specialist. But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors. So addressing low desire means engaging with everything from partnership issues to hormonal changes. Postmenopausal females experience a broad range of symptoms that can impact sexual desire. Menopausal symptoms include: sudden feelings of heat lack of natural lubrication discomfort with sex insomnia urinary incontinence According to one expert, treating these issues is often a first step toward sexual wellness. “When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said. The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly vaginal dryness. She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less concerned about it and to view it as a viable choice. Androgen therapy is also occasionally used without formal approval to address low libido in women, although it is not indicated for it. But in addition to drugs, experts say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy. “I would have no problem prescribing flibanserin after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said. Other recommendations for increasing sexual desire include: getting more sleep engaging in physical activity staying active using over-the-counter lubricants engaging in extended foreplay incorporating sexual wellness devices or vaginal dilators “It requires an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “This involves understanding 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.”