🔗 Share this article U.S. Food and Drug Administration Approves Addyi, a Desire-Boosting Treatment for Females Beyond Menopause Flibanserin, sometimes referred to as “the women's Viagra,” is now cleared for treatment to treat diminished libido in females beyond reproductive age. The FDA expanded its approval of flibanserin, a pill to treat hypoactive sexual desire disorder (HSDD) in women, to include postmenopausal women up to age 65. The approval will provide fresh choices for older women, but experts caution that treating low libido requires a “whole body approach.” This drug presents serious risks with drinking that may lead to loss of consciousness, so refraining from drinking is essential. U.S. regulators widened the indication of a oral treatment to treat low libido in women to include postmenopausal women up to 65 years old. Before the recent news, the pill, 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 protracted and controversial review process. The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits. Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019. The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s action to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health. Other women’s health experts 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 OB-GYN. “Getting the FDA approval for this group of women could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.” A clinical professor told news outlets that the decision was “logical” given the available data. While in favor, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the placebo, but the extent of the enhancement is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?” Understanding Flibanserin, the ‘Women's Desire Pill’? Flibanserin, which is often called “the women's version of Viagra,” has little in common with the drug from which it gets its informal name. The drug was first created as an medication for depression but was found to be lacking during initial trials. However, scientists observed improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for low libido. Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign. Addyi carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol. The label advises allowing a two-hour gap after drinking before taking Addyi to minimize the chance of fainting. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely. Claims about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the combination. The research, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had reservations. “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 public health expert stated. An gynecologist suggested that this may have been part of the cause why the drug 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 drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said. Another doctor expressed uncertainty about why the expanded indication was capped at 65 years of age. “It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said. Treating Low Libido After Menopause Despite these risks, Addyi could still broaden treatment options for low desire to a new population of women who may benefit. “I believe it will benefit this demographic better as long as they have no other health issues,” said an specialist. But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors. So treating HSDD means considering everything from partnership issues to shifts in hormone levels. Women after menopause experience a broad range of symptoms that can affect sexual desire. Symptoms of menopause include: sudden feelings of heat vaginal dryness pain during intercourse insomnia bladder leakage According to one expert, managing these issues is often a first step toward improved intimacy. “When a patient presents with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said. The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly vaginal dryness. She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a viable choice. Androgen therapy is also occasionally used without formal approval to address reduced desire in females, although it is not indicated for it. But besides medication, doctors say that personal habits should also be factored in. Discussions about sexual desire almost always start with relationships and intimacy. “I would have no problem recommending Addyi 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 recommendations for increasing libido are: getting more sleep engaging in physical activity staying active using over-the-counter personal lubricants engaging in extended foreplay incorporating vibrators or dilators “It requires an entire whole body approach to sexual health and this life stage in later life,” said an expert. “That means understanding how your body works, your anatomy, 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.”