🔗 Share this article FDA Grants Approval to Flibanserin, a Libido-Enhancing Drug for Females Beyond Menopause Flibanserin, colloquially known as “the women's Viagra,” is now approved for use to treat diminished libido in females beyond reproductive age. The FDA expanded its approval of Addyi, a oral medication to address hypoactive sexual desire disorder (HSDD) in women, to include women after menopause up to age 65. The regulatory green light will unlock additional therapeutic avenues for this demographic, but health professionals advise that treating low libido requires a “holistic method.” The medication carries potentially dangerous interactions with alcohol that may result in syncope, so avoiding alcoholic beverages is recommended. The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to the age of sixty-five. Prior to this week's decision, the drug, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females. Flibanserin was originally authorized by the FDA in 2015, following a long and debated evaluation period. Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile. Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019. The chief executive of the maker of flibanserin commended the FDA’s decision to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health. Additional women’s health experts expressed support for the decision. “Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be crucial to address women after menopause 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 approval was “logical” given the existing research. While in favor, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the improvement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?” What is Flibanserin, the ‘Women's Desire Pill’? Addyi, which is often called “female Viagra,” has few similarities 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. Nevertheless, researchers observed improvements in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for low libido. After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign. The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks. The label recommends allowing a two-hour gap after drinking before taking the drug to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely. Claims about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the combination. The research, which were limited in size, showed 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 aren’t very long,” a public health expert stated. An OB-GYN speculated that this may have been part of the cause why the drug was not originally approved for postmenopausal women. “Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said. Another doctor expressed confusion about why the expanded indication was capped at 65 years of age. “It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said. Treating Low Libido After Menopause Despite these risks, flibanserin could still expand treatment options for low desire to a different group 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 specialists consulted all agreed that the female libido is complex and multifaceted. So addressing low desire means engaging with everything from relationship dynamics to hormonal changes. Women after menopause experience a wide variety of symptoms that can affect libido. Symptoms of menopause include: sudden feelings of heat vaginal dryness discomfort with sex insomnia bladder leakage According to one expert, treating these issues is often a initial approach toward sexual wellness. “If somebody came to me 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 options to alleviate the symptoms of menopause, particularly dryness. She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice. Testosterone is also occasionally used without formal approval to treat low libido in females, although it is not indicated for it. But besides medication, experts say that personal habits should also be factored in. Conversations about sexual desire almost always start with partnership dynamics and closeness. “I would have no problem prescribing 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 recommendations for boosting sexual desire are: improving sleep hygiene exercising staying active using over-the-counter personal lubricants practicing extended intimate stimulation incorporating sexual wellness devices or vaginal dilators “It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “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 excited, and ultimately to have a climax of orgasm.”