🔗 Share this article FDA Approves Addyi, a Libido-Enhancing Drug for Postmenopausal Addyi, sometimes referred to as “female Viagra,” is now approved for use to combat diminished libido in women after menopause. Regulators broadened the indication of Addyi, a pill to address low libido in women, to include postmenopausal women up to age 65. The regulatory green light will unlock new treatment options for this demographic, but specialists warn that addressing HSDD requires a “comprehensive strategy.” Addyi is known to have serious risks with alcohol that may cause loss of consciousness, so avoiding alcoholic beverages is strongly advised. The federal agency broadened the authorized use of a daily pill to manage low libido in women to cover postmenopausal women up to the age of sixty-five. Before the recent news, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age. Flibanserin was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period. Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA cited issues about safety, effectiveness, and an concerning balance of risks and benefits. Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen. The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s move to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health. Additional specialists in female health expressed support for the decision. “Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be significant to address postmenopausal women 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 “understandable” given the clinical evidence. Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference 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 seeing a major effect?” Understanding Addyi, the ‘Female Viagra’? Flibanserin, which is sometimes referred to as “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 antidepressant but was found to be lacking during initial trials. However, scientists noted improvements in measures of sexual function and shifted focus to the drug’s potential as a therapy for low libido. After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort. The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol. The label advises allowing a two-hour gap after consuming alcohol before using Addyi to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely. Claims about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns. “These studies don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated. An gynecologist speculated that this may have been part of the reason why the drug was not initially cleared for postmenopausal women. “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 susceptible to things like that,” she said. Another doctor echoed uncertainty about why the expanded indication was capped at age 65. “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 cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said. Treating Diminished Sexual Desire After Menopause Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire to a different group of women who may find help. “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 female libido is complex and multifaceted. So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels. Postmenopausal females navigate a broad range of symptoms that can impact sexual desire. Symptoms of menopause include: hot flashes vaginal dryness pain during intercourse insomnia urinary incontinence As noted by one expert, treating these issues is often a initial approach toward improved intimacy. “When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly dryness. She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option. Testosterone is also sometimes prescribed off-label to treat low libido in females, although it is not indicated for it. But besides medication, experts say that personal habits should also be considered. Conversations about sexual desire almost always begin by focusing on relationships and intimacy. “I would have no problem prescribing Addyi 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. Other suggestions for boosting libido are: getting more sleep engaging in physical activity staying active applying over-the-counter lubricants engaging in extended intimate stimulation using vibrators or vaginal dilators “It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “This involves 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 climax of sexual pleasure.”