🔗 Share this article FDA Grants Approval to Addyi, a Desire-Boosting Drug for Women After Menopause Flibanserin, colloquially known as “the women's Viagra,” is now cleared for treatment to address reduced sexual desire in women after menopause. The FDA expanded its approval of Addyi, a pill to address hypoactive sexual desire disorder (HSDD) in women, to encompass women after menopause up to age 65. The approval will unlock additional therapeutic avenues for this demographic, but health professionals advise that treating low libido requires a “whole body approach.” The medication carries potentially dangerous interactions with alcohol that may result in syncope, so abstinence from alcohol is recommended. The Food and Drug Administration (FDA) expanded its approval of a daily pill to manage low libido in women to now encompass postmenopausal women up to the age of sixty-five. Prior to the announcement, the drug, Addyi (flibanserin), was only approved to address low sexual desire in women of reproductive age. This medication was first approved by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny. Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile. Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen. The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health. Other women’s health experts voiced approval for the regulatory move. “There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be significant to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.” A clinical professor told news outlets that the decision 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 inactive pill, but the magnitude of the benefit is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?” What is Addyi, the ‘Female Viagra’? Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname. The drug was initially researched as an antidepressant but was considered unsuccessful during initial trials. Nevertheless, scientists noted positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire. After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major advocacy campaign. The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol. Official guidance advises allowing a two-hour gap after drinking before taking the drug to reduce the risk of fainting. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely. Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were small in scale, showed no increased danger of syncope. But experts had concerns. “This research don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated. An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for older females. “Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said. Another doctor echoed uncertainty about why the broader approval 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 dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said. Treating Diminished Sexual Desire in Postmenopausal Women Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a different group of women who may benefit. “I believe it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN. But it is not a quick fix. In fact, the specialists consulted all agreed that the female libido is complex and multifaceted. So treating low desire means engaging with everything from relationship dynamics to hormonal changes. Postmenopausal females navigate a broad range of changes that can impact sexual desire. Menopausal symptoms encompass: hot flashes lack of natural lubrication pain during intercourse insomnia bladder leakage According to one expert, managing these symptoms is often a first step toward improved intimacy. “If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert recommended both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly vaginal dryness. She hopes that the FDA’s recent removal of its “serious” 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 prescribed off-label to treat reduced desire in females, although it is not indicated for it. But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always start with relationships and intimacy. “I am comfortable prescribing flibanserin after discussing it 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 boosting libido are: getting more sleep exercising staying active applying over-the-counter personal lubricants practicing extended intimate stimulation using sexual wellness devices or vaginal dilators “It requires an entire whole body approach to sexuality and this life stage in older age,” said an expert. “This involves knowing 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.”