🔗 Share this article U.S. Food and Drug Administration Approves Flibanserin, a Desire-Boosting Treatment for Females Beyond Menopause Flibanserin, colloquially known as “female Viagra,” is now cleared for treatment to treat diminished libido in females beyond reproductive age. Regulators broadened the indication of Addyi, a pill to address low libido in women, to include postmenopausal women up to age 65. The approval will open up fresh choices for older women, but health professionals advise that addressing HSDD requires a “whole body approach.” This drug presents potentially dangerous interactions with alcohol that may lead to fainting, so avoiding alcoholic beverages is essential. The Food and Drug Administration (FDA) widened the indication of a daily pill to manage low libido in females to now encompass postmenopausal women up to 65 years old. Prior to this week's decision, the pill, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females. Flibanserin was initially cleared by the FDA in 2015, following a protracted and controversial review process. The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA raised concerns about safety, efficacy, and an unfavorable risk–benefit profile. Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019. The chief executive of the maker of flibanserin praised the FDA’s decision to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness. Additional specialists in female health were supportive for the decision. “Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be crucial to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with 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 measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?” What is Addyi, the ‘Female Viagra’? Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the drug from which it gets its informal name. The drug was originally developed as an antidepressant but was deemed ineffective during initial trials. Nevertheless, researchers noted improvements in measures of sexual function and redirected efforts to the drug’s possible use as a therapy for low libido. Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort. The medication carries a boxed (“black box”) warning for serious side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks. The label advises allowing a two-hour gap after drinking before using Addyi to minimize the risk of syncope. If a person has three or more alcoholic drinks on a given day, the instructions recommends skipping the dose entirely. Claims about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the combination. The studies, which were small in scale, showed no additional risk of fainting. But experts had concerns. “This research aren't very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated. An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women. “There have been adverse reactions like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said. Another doctor echoed confusion about why the expanded indication was limited at 65 years of age. “It's unclear if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said. Treating Low Libido After Menopause Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a new population of women who may benefit. “I do think it will serve this population 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 interviewed 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. Women after menopause navigate a wide variety of symptoms that can affect sexual desire. Menopausal symptoms include: sudden feelings of heat vaginal dryness discomfort with sex insomnia bladder leakage According to one expert, treating these symptoms is often a first step toward sexual wellness. “If somebody came to me with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness. She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a viable choice. Androgen therapy is also occasionally used without formal approval to address low libido in females, although it is not indicated for it. But besides medication, doctors say that personal habits should also be considered. Conversations about libido almost always begin by focusing on relationships and intimacy. “I am comfortable prescribing 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 recommendations for boosting libido are: improving sleep hygiene exercising staying active using over-the-counter lubricants engaging in extended foreplay using sexual wellness devices or vaginal dilators “You have to take an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “This involves knowing how your body works, your anatomy, 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 sexual pleasure.”