🔗 Share this article FDA Grants Approval to Addyi, a Libido-Enhancing Treatment for Females Beyond Menopause Addyi, sometimes referred to as “the women's Viagra,” is now approved for use to treat low sex drive in females beyond reproductive age. The agency widened the authorized use of flibanserin, a pill to treat hypoactive sexual desire disorder (HSDD) in women, to include postmenopausal women up to age 65. The regulatory green light will unlock fresh choices for this demographic, but specialists warn that treating low libido requires a “holistic method.” The medication carries potentially dangerous interactions with drinking that may lead to fainting, so abstinence from alcohol is essential. The federal agency broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to age 65. Prior to the announcement, the medication, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females. Flibanserin was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period. Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile. Now, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019. The chief executive of the maker of flibanserin commended the FDA’s action to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness. Additional OB-GYNs voiced approval for the regulatory move. “I had few tools for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be very important 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 news outlets that the approval was “logical” given the available data. Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, 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 ‘Female Viagra’? Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it gets its informal name. This medication was first created as an medication for depression but was considered unsuccessful during early studies. Nevertheless, scientists noted positive changes in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido. Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major 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 alcohol. The label recommends allowing a two-hour gap after drinking before taking the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely. Assertions about the interactions of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the combination. The research, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations. “This research aren't very persuasive to me. They are a beginning, but they’re not very large-scale 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 initially cleared 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 susceptible to effects like that,” she said. Another doctor echoed confusion about why the broader approval was capped at age 65. “I don’t know if that has to do with the intricacies of the drug. 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 simpler guidance because it may affect our prescribing,” he said. Treating Low Libido in Postmenopausal Women Despite these risks, flibanserin could still expand therapeutic choices for low desire 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 specialist. But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted. So addressing HSDD means considering everything from relationship dynamics to shifts in hormone levels. Postmenopausal females experience a wide variety of changes that can affect sexual desire. Menopausal symptoms encompass: hot flashes lack of natural lubrication discomfort with sex insomnia urinary incontinence According to one expert, managing these issues is often a initial approach toward improved intimacy. “If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said. The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly dryness. She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option. Testosterone is also sometimes prescribed off-label to treat low libido in women, although it is not officially approved for it. But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about libido almost always start with partnership dynamics and closeness. “I would have no problem recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said. Additional recommendations for boosting libido include: getting more sleep engaging in physical activity maintaining an active lifestyle applying over-the-counter lubricants engaging in extended intimate stimulation incorporating vibrators or dilators “It requires an entire whole body approach to sexual health and this life stage in older age,” said an expert. “That means understanding how your body works, your physiology, 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 sexual pleasure.”