🔗 Share this article FDA Approves Flibanserin, a Libido-Enhancing Treatment for Females Beyond Menopause Addyi, colloquially known as “female Viagra,” is now cleared for treatment to address diminished libido in women after menopause. Regulators broadened the indication of flibanserin, a oral medication to treat hypoactive sexual desire disorder (HSDD) in women, to encompass postmenopausal women up to age 65. The regulatory green light will open up additional therapeutic avenues for this demographic, but specialists warn that treating low libido requires a “holistic method.” Addyi is known to have potentially dangerous interactions with alcohol that may cause syncope, so refraining from drinking is strongly advised. U.S. regulators expanded its approval of a daily pill to address low libido in females to cover postmenopausal women up to 65 years old. Prior to the recent news, the drug, Addyi (flibanserin), was exclusively cleared to address low sexual desire in women of reproductive age. The drug was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny. The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile. Today, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019. The founder and CEO of the maker of Addyi praised the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness. Other women’s health experts were supportive for the decision. “I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be crucial to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.” A professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the existing research. Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?” What is Addyi, the ‘Women's Desire Pill’? Flibanserin, which is often called “the women's version of 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 early studies. Nevertheless, scientists noted positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire. After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort. The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks. Official guidance advises allowing a two-hour gap after drinking before using the drug to reduce the chance of syncope. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely. Assertions about the interactions of mixing the drug with drinking eventually led the maker to fund additional studies investigating the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had reservations. “This research aren't very persuasive 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 the drug was not originally approved for older females. “There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said. Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age. “It's unclear if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, 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 Diminished Sexual Desire After Menopause Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a new population of females who may benefit. “I do think it will benefit this population better as long as they have no other health issues,” said an OB-GYN. But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors. So addressing HSDD means considering everything from relationship dynamics to shifts in hormone levels. Women after menopause navigate a wide variety of changes that can affect sexual desire. Symptoms of menopause include: hot flashes vaginal dryness discomfort with sex sleep disturbances urinary incontinence According to one expert, managing these issues is often a first step toward sexual wellness. “When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to treat the effects of menopause, particularly 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 consider it as a viable choice. Testosterone is also occasionally used without formal approval to treat reduced desire in women, although it is not officially approved for it. But besides medication, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness. “I would have no problem recommending 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. Additional suggestions for increasing libido include: getting more sleep engaging in physical activity staying active using over-the-counter lubricants engaging in extended intimate stimulation using sexual wellness devices or vaginal dilators “It requires an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “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 excited, and ultimately to have a peak of orgasm.”