🔗 Share this article U.S. Food and Drug Administration Approves Addyi, a Desire-Boosting Drug for Postmenopausal Addyi, often called “female Viagra,” is now cleared for treatment to treat low sex drive in females beyond reproductive age. The agency widened the authorized use of Addyi, a daily drug to treat hypoactive sexual desire disorder (HSDD) in women, to include postmenopausal women up to age 65. This decision will open up fresh choices for this demographic, but health professionals advise that treating low libido requires a “comprehensive strategy.” The medication carries serious risks with drinking that may result in syncope, so avoiding alcoholic beverages is recommended. The federal agency expanded its approval of a oral treatment to treat low libido in females to cover postmenopausal women up to 65 years old. Before this week's decision, the drug, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in premenopausal females. The drug was originally authorized by the FDA in 2015, following a lengthy and contentious regulatory scrutiny. Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits. Now, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019. The founder and CEO of the maker of Addyi applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness. Additional OB-GYNs expressed support for the decision. “Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population 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 reporters that the approval was “understandable” given the available data. While in favor, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?” Understanding Flibanserin, the ‘Female Viagra’? Flibanserin, which is often called “female Viagra,” has significant differences with the drug from which it gets its informal name. The drug was initially researched as an antidepressant but was found to be lacking during early studies. Nevertheless, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a therapy for diminished sexual desire. Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable lobbying effort. Addyi carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks. Official guidance recommends waiting at least two hours after consuming alcohol before taking the drug to minimize the risk of syncope. If a person has several drinks on a given day, the instructions recommends skipping the dose entirely. Claims about the interactions of mixing the drug with drinking eventually prompted the maker to fund further research investigating the combination. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations. “These studies don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated. An OB-GYN suggested 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 individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said. Another doctor expressed confusion about why the broader approval was limited at age 65. “It's unclear if that has to do with the complexity of the drug. If you take 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 clearer instructions because it may affect our prescribing,” he said. Treating Low Libido in Postmenopausal Women Despite these risks, Addyi could still expand therapeutic choices for low desire to a new population of women 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 quick fix. In fact, the specialists consulted universally acknowledged that the women's sexual desire is complex and multifaceted. So addressing HSDD means engaging with everything from partnership issues to shifts in hormone levels. Women after menopause navigate a broad range of symptoms that can affect libido. Menopausal symptoms encompass: sudden feelings of heat vaginal dryness discomfort with sex insomnia urinary incontinence According to one expert, managing these symptoms is often a initial approach toward sexual wellness. “If somebody came to me with concerns about desire, my initial inquiry 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 treat the effects of menopause, particularly vaginal dryness. She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option. Androgen therapy is also occasionally used without formal approval to address reduced desire in women, although it is not officially approved for it. But in addition to drugs, experts say that personal habits should also be factored in. Conversations about libido almost always begin by focusing on relationships and intimacy. “I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said. Other suggestions for increasing libido include: improving sleep hygiene exercising maintaining an active lifestyle applying over-the-counter personal lubricants engaging in extended intimate stimulation using sexual wellness devices or vaginal dilators “You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “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 excited, and ultimately to have a peak of sexual pleasure.”