🔗 Share this article FDA Clears Flibanserin, a Libido-Enhancing Medication for Women After Menopause Flibanserin, often called “the women's Viagra,” is now approved for use to combat reduced sexual desire in postmenopausal women. The agency widened the authorized use of Addyi, a daily drug to address low libido in women, to include postmenopausal women up to age 65. The approval will provide new treatment options for this demographic, but specialists warn that addressing HSDD requires a “comprehensive strategy.” The medication carries serious risks with alcohol that may cause syncope, so avoiding alcoholic beverages is essential. The federal agency broadened the authorized use of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to the age of sixty-five. Prior to the announcement, the drug, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age. The drug was originally authorized by the FDA in 2015, following a lengthy and contentious review process. The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile. Currently, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019. The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s action to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health. Other OB-GYNs expressed support for the decision. “Previously, options were limited for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, 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 guarded in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?” What is Addyi, the ‘Women's Desire Pill’? Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it draws its nickname. The drug was initially researched as an medication for depression but was deemed ineffective during early studies. However, researchers observed improvements in measures of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire. Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a major advocacy campaign. Addyi carries a serious safety warning for potentially dangerous adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks. The label advises allowing a two-hour gap after consuming alcohol before taking the drug to reduce the risk of syncope. If a person has several drinks on a given day, the instructions advises skipping the dose entirely. Claims about the interactions of mixing the drug with drinking eventually led the maker to fund further research investigating the combination. The research, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had concerns. “This research don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a health research president stated. An gynecologist speculated that this may have been part of the cause why the drug was not initially cleared for older females. “There have been 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 older, you become more sensitive to things like that,” she said. Another doctor echoed uncertainty about why the broader approval was limited at age 65. “It's unclear if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said. Treating Low Libido in Postmenopausal Women Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a different group of females 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 simple solution. In fact, the specialists consulted all agreed that the women's sexual desire is complex and multifaceted. So addressing HSDD means engaging with everything from partnership issues to hormonal changes. Postmenopausal females experience a wide variety of symptoms that can affect sexual desire. Symptoms of menopause encompass: sudden feelings of heat lack of natural lubrication discomfort with sex sleep disturbances bladder leakage As noted by one expert, managing these symptoms is often a first step toward improved intimacy. “When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said. The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly vaginal dryness. She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a viable choice. Androgen therapy is also occasionally prescribed off-label to treat reduced desire in women, although it is not officially approved for it. But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness. “I would have no problem recommending 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. Additional suggestions for increasing libido include: getting more sleep engaging in physical activity staying active using over-the-counter lubricants engaging in extended foreplay incorporating vibrators or vaginal dilators “You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves knowing how your body works, your physiology, 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.”