🔗 Share this article U.S. Food and Drug Administration Clears Flibanserin, a Libido-Enhancing Medication for Postmenopausal Addyi, sometimes referred to as “the women's Viagra,” is now cleared for treatment to address reduced sexual desire in postmenopausal women. Regulators broadened the indication of Addyi, a pill to address hypoactive sexual desire disorder (HSDD) in women, to encompass postmenopausal women up to age 65. The regulatory green light will unlock new treatment options for older women, but experts caution that addressing HSDD requires a “whole body approach.” Addyi is known to have potentially dangerous interactions with alcohol that may cause syncope, so abstinence from alcohol is recommended. The federal agency widened the indication of a once-a-day medication to treat low libido in women to cover women after menopause up to age 65. Before this week's decision, the medication, Addyi (flibanserin), was only approved to address low sexual desire in premenopausal females. Flibanserin was initially cleared by the FDA in 2015, following a lengthy and contentious regulatory scrutiny. The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile. Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019. The chief executive of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health. Other OB-GYNs were supportive for the decision. “There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.” A professor of obstetrics and gynecology told reporters that the approval was “logical” given the available data. Although supportive, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the enhancement is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?” What is Flibanserin, the ‘Women's Desire Pill’? Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it gets its informal name. This medication was first created as an antidepressant but was found to be lacking during early studies. Nevertheless, researchers noted positive changes in measures of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire. Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort. Addyi carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol. Official guidance advises waiting at least two hours after consuming alcohol before taking the drug to reduce the risk of fainting. 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 interaction. The research, which were small in scale, showed no additional risk of fainting. But experts had concerns. “This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert stated. An gynecologist suggested that this may have been part of the reason why the drug was not initially cleared for postmenopausal women. “Patients have experienced side effects like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said. Another doctor expressed confusion about why the expanded indication was limited at 65 years of age. “It's unclear if that has to do with the intricacies of the medication. If you take 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 prescribing,” he said. Addressing Diminished Sexual Desire After Menopause Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for low desire to a different group of women who may find help. “I believe it will serve this demographic better as long as they have no other medical problems,” said an specialist. But it is not a magic bullet. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors. So addressing low desire means considering everything from partnership issues to hormonal changes. Postmenopausal females experience a broad range of changes that can affect sexual desire. Menopausal symptoms encompass: sudden feelings of heat lack of natural lubrication pain during intercourse sleep disturbances bladder leakage As noted by one expert, managing these symptoms is often a first step toward sexual wellness. “If somebody came to me with libido issues, 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 vaginal dryness. She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice. Androgen therapy is also occasionally prescribed off-label to address low libido in women, although it is not officially approved for it. But besides medication, experts say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy. “I would have no problem prescribing flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said. Other recommendations for boosting libido are: getting more sleep exercising staying active using over-the-counter personal lubricants engaging in extended intimate stimulation using vibrators or dilators “You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “This involves knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”