🔗 Share this article U.S. Food and Drug Administration Clears Flibanserin, a Libido-Enhancing Medication for Females Beyond Menopause Flibanserin, often called “the women's Viagra,” is now approved for use to combat low sex drive in women after menopause. Regulators broadened the indication of Addyi, a daily drug to address hypoactive sexual desire disorder (HSDD) in women, to include postmenopausal women up to age 65. This decision will provide new treatment options for older women, but experts caution that treating low libido requires a “comprehensive strategy.” Addyi is known to have potentially dangerous interactions with drinking that may cause syncope, so refraining from drinking is recommended. The federal agency widened the indication of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to 65 years old. Prior to the announcement, the medication, flibanserin (Addyi), was only approved to address low sexual desire in women of reproductive age. Flibanserin was initially cleared by the FDA in two thousand fifteen, following a long and debated review process. The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency cited issues about safety, effectiveness, and an concerning balance of risks and benefits. Today, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019. The chief executive of the maker of Addyi praised the FDA’s move to expand the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness. Additional women’s health experts were supportive for the decision. “Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be significant to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.” A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the clinical evidence. Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the improvement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?” What is Addyi, the ‘Women's Desire Pill’? Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname. The drug was initially researched as an medication for depression but was considered unsuccessful during early studies. Nevertheless, scientists observed improvements in aspects of sexual function and shifted focus to the drug’s potential as a treatment for low libido. Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign. The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure 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 chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely. Assertions about the interactions of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The research, which were small in scale, showed no additional risk of syncope. But medical professionals had concerns. “This research don’t seem very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated. An gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared for older females. “There have been side effects like the fainting spells and dizziness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more sensitive to things like that,” she said. Another doctor expressed uncertainty about why the expanded indication was capped at 65 years of age. “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 cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said. Addressing Diminished Sexual Desire in Postmenopausal Women Despite these risks, Addyi could still expand treatment options for HSDD to a new population of women who may benefit. “I do think it will serve this demographic better as long as they have no other health issues,” said an OB-GYN. But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the female libido is influenced by many factors. So treating low desire means engaging with everything from relationship dynamics to hormonal changes. Postmenopausal females navigate a wide variety of symptoms that can impact libido. Symptoms of menopause include: hot flashes lack of natural lubrication discomfort with sex insomnia bladder leakage According to one expert, treating these symptoms is often a initial approach toward sexual wellness. “If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly vaginal dryness. She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to view it as a viable choice. Testosterone is also sometimes used without formal approval to address low libido in females, although it is not officially approved for it. But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on relationships and intimacy. “I would have no problem 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 recommendations for boosting libido include: getting more sleep engaging in physical activity staying active applying over-the-counter personal lubricants engaging in extended foreplay incorporating vibrators or vaginal dilators “You have to take an entire whole body approach to sexual health and menopause in later life,” said an expert. “This involves understanding 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 peak of orgasm.”