🔗 Share this article FDA Grants Approval to Addyi, a Desire-Boosting Medication for Females Beyond Menopause Flibanserin, sometimes referred to as “female Viagra,” is now cleared for treatment to combat low sex drive in females beyond reproductive age. The FDA expanded its approval of Addyi, a oral medication to address hypoactive sexual desire disorder (HSDD) in women, to encompass postmenopausal women up to age 65. The approval will open up fresh choices for this demographic, but health professionals advise that addressing HSDD requires a “whole body approach.” This drug presents potentially dangerous interactions with drinking that may lead to syncope, so avoiding alcoholic beverages is recommended. The federal agency expanded its approval of a daily pill to manage low libido in females to cover postmenopausal women up to 65 years old. Prior to the announcement, the medication, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age. This medication was originally authorized by the FDA in two thousand fifteen, following a long and debated review process. Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile. Currently, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019. The founder and CEO of the maker of Addyi applauded the FDA’s move to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health. Additional specialists in female health expressed support for the decision. “There was nothing for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.” A clinical professor told news outlets that the approval was “logical” given the existing research. Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the benefit is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?” What is Flibanserin, the ‘Female Viagra’? Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname. The drug was originally developed as an antidepressant but was considered unsuccessful during early studies. Nevertheless, researchers noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for low libido. After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a significant 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 alcoholic drinks. Official guidance advises waiting at least two hours after consuming alcohol before using Addyi to minimize the risk of syncope. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely. Assertions about the effects of mixing the drug with drinking eventually led the maker to fund further research examining the interaction. The studies, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had concerns. “These studies aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president stated. An gynecologist suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women. “There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to effects 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 drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance 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 low desire to a different group of females who may benefit. “I believe 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 specialists interviewed all agreed that the female libido is complex and multifaceted. So addressing HSDD means engaging with everything from partnership issues to hormonal changes. Postmenopausal females experience a wide variety of changes that can affect sexual desire. Menopausal symptoms encompass: sudden feelings of heat vaginal dryness discomfort with sex sleep disturbances urinary incontinence As noted by one expert, treating these issues is often a first step toward sexual wellness. “If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said. The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the symptoms of menopause, particularly vaginal dryness. She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less concerned about it and to view it as a viable choice. Testosterone is also occasionally prescribed off-label to address reduced desire in women, although it is not officially approved for it. But in addition to drugs, experts say that lifestyle should also be considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness. “I am comfortable recommending flibanserin 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 increasing sexual desire are: getting more sleep engaging in physical activity maintaining an active lifestyle using over-the-counter lubricants practicing extended intimate stimulation incorporating vibrators or vaginal dilators “It requires an entire whole body approach to sexuality and menopause in later life,” 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 orgasm.”