🔗 Share this article FDA Clears Flibanserin, a Desire-Boosting Medication for Women After Menopause Flibanserin, sometimes referred to as “female Viagra,” is now approved for use to combat diminished libido in females beyond reproductive age. Regulators broadened the indication of flibanserin, a oral medication 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 health professionals advise that treating low libido requires a “comprehensive strategy.” Addyi is known to have serious risks with alcohol that may cause syncope, so abstinence from alcohol is recommended. U.S. regulators expanded its approval of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to the age of sixty-five. Before the announcement, the pill, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age. This medication was first approved by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny. The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits. Now, flibanserin 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 founder and CEO of the maker of flibanserin applauded the FDA’s move to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health. Other OB-GYNs voiced approval for the regulatory move. “There was nothing for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be significant to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.” A clinical professor told reporters that the approval was “logical” given the clinical evidence. While in favor, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not getting bang for your buck?” What is Flibanserin, the ‘Women's Desire Pill’? Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname. The drug was initially researched as an medication for depression but was found to be lacking during initial trials. Nevertheless, scientists noted improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire. Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort. Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol. The label recommends waiting at least two hours after drinking before using Addyi to minimize the risk of fainting. If a person has several drinks on a given day, the label recommends skipping the dose entirely. Claims about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research investigating the interaction. The research, which were small in scale, demonstrated no increased danger of syncope. But experts had concerns. “This research aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated. An OB-GYN 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 syncopal episodes and dizziness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said. Another doctor expressed confusion about why the expanded indication was limited at age 65. “I don’t know if that has to do with the complexity of the drug. Reviewing a list of the instructions and restrictions, 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 in Postmenopausal Women Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a new population of women who may benefit. “I do think it will benefit this demographic better as long as they have no other health issues,” said an OB-GYN. But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the women's sexual desire is influenced by many factors. So addressing low desire means considering everything from relationship dynamics to hormonal changes. Women after menopause experience a broad range of changes that can impact libido. Menopausal symptoms encompass: sudden feelings of heat vaginal dryness discomfort with sex sleep disturbances bladder leakage As noted by one expert, treating 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 recommended both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly vaginal dryness. She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less concerned about it and to consider it as a treatment option. Androgen therapy is also occasionally prescribed off-label to address reduced desire in women, although it is not indicated for it. But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about libido almost always begin by focusing on relationships and intimacy. “I am comfortable recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said. Additional recommendations for boosting sexual desire include: improving sleep hygiene engaging in physical activity maintaining an active lifestyle using over-the-counter personal lubricants engaging in extended intimate stimulation incorporating sexual wellness devices or 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 anatomy, 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.”