🔗 Share this article FDA Clears Addyi, a Desire-Boosting Drug for Women After Menopause Flibanserin, sometimes referred to as “female Viagra,” is now cleared for treatment to address diminished libido in females beyond reproductive age. Regulators broadened the indication of flibanserin, a oral medication to address hypoactive sexual desire disorder (HSDD) in women, to include postmenopausal women up to age 65. The approval will open up fresh choices for older women, but specialists warn that treating low libido requires a “holistic method.” This drug presents potentially dangerous interactions with alcohol that may lead to fainting, so avoiding alcoholic beverages is essential. U.S. regulators broadened the authorized use of a daily pill to manage low libido in women to cover postmenopausal women up to age 65. Prior to the recent news, the pill, Addyi (flibanserin), was only approved to address low sexual desire in women of reproductive age. The drug was originally authorized by the FDA in 2015, following a protracted and controversial review process. Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about safety, effectiveness, and an concerning balance of risks and benefits. Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen. The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s action to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness. Additional women’s health experts expressed support for the decision. “There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be very important to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.” A clinical professor told reporters that the approval was “understandable” given the existing research. 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 benefit is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?” Understanding Flibanserin, the ‘Female Viagra’? 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 originally developed as an antidepressant but was found to be lacking during initial trials. Nevertheless, researchers observed positive changes in aspects of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire. After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major advocacy campaign. Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol. Official guidance recommends waiting at least two hours after drinking before using Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a given day, the label advises not taking the pill entirely. Assertions about the effects of mixing Addyi and alcohol eventually led the maker to fund further research investigating the combination. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns. “This research aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” 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 older females. “There have been side effects 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 things like that,” she said. Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age. “I don’t know if that has to do with the complexity of the drug. If you take 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 prescribing,” he said. Treating Diminished Sexual Desire After Menopause Despite these risks, Addyi could still expand therapeutic choices for low desire to a new population of women who may find help. “I do think it will serve this population better as long as they have no other medical problems,” said an OB-GYN. But it is not a simple solution. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors. So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels. Women after menopause navigate a wide variety of symptoms that can impact libido. Symptoms of menopause include: sudden feelings of heat lack of natural lubrication pain during intercourse insomnia bladder leakage As noted by 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: Are you experiencing vaginal discomfort? Is intercourse painful?” she said. The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate 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 consider it as a treatment option. Testosterone is also sometimes prescribed off-label to treat reduced desire in women, although it is not officially approved for it. But besides medication, experts say that lifestyle should also be factored in. Discussions about libido almost always start with partnership dynamics and closeness. “I am comfortable prescribing 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 libido are: getting more sleep engaging in physical activity maintaining an active lifestyle applying over-the-counter lubricants practicing extended intimate stimulation using sexual wellness devices or vaginal dilators “It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” 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 climax of sexual pleasure.”