🔗 Share this article FDA Approves Addyi, a Desire-Boosting Medication for Postmenopausal Addyi, colloquially known as “female Viagra,” is now approved for use to combat diminished libido in women after menopause. The FDA expanded its approval of Addyi, a oral medication to address hypoactive sexual desire disorder (HSDD) in women, to encompass postmenopausal women up to age 65. This decision will open up fresh choices for this demographic, but health professionals advise that addressing HSDD requires a “holistic method.” Addyi is known to have potentially dangerous interactions with drinking that may cause loss of consciousness, so avoiding alcoholic beverages is recommended. U.S. regulators broadened the authorized use of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to age 65. Before this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age. Flibanserin was first approved by the FDA in two thousand fifteen, following a long and debated evaluation period. Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits. Today, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019. The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s move to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health. Other OB-GYNs expressed support for the regulatory move. “Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “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 experience pleasure, but sometimes have problems regarding libido.” A professor of obstetrics and gynecology told news outlets that the decision was “understandable” given the available data. Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not substantial. Does it justify taking a drug daily and not getting bang for your buck?” Understanding Addyi, the ‘Women's Desire Pill’? Flibanserin, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it draws its nickname. The drug was initially researched as an antidepressant but was found to be lacking during early studies. Nevertheless, scientists observed positive changes in aspects of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido. After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort. Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol. Official guidance recommends allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of syncope. If a person consumes several drinks on a single occasion, the instructions recommends not taking the pill entirely. Assertions about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of syncope. But medical professionals had concerns. “This research don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated. An gynecologist speculated that this may have been part of the reason why Addyi was not originally approved for older females. “Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said. Another doctor expressed uncertainty about why the broader approval 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, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said. Treating Low Libido After Menopause Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a different group of women who may benefit. “I do think it will serve this population better as long as they have no other medical problems,” said an specialist. But it is not a simple solution. In fact, the specialists consulted universally acknowledged that the women's sexual desire is influenced by many factors. So treating HSDD means engaging with everything from relationship dynamics to shifts in hormone levels. Women after menopause navigate a broad range of symptoms that can affect libido. Symptoms of menopause include: sudden feelings of heat lack of natural lubrication discomfort with sex sleep disturbances bladder leakage As noted by one expert, treating these issues is often a first step toward sexual wellness. “When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly dryness. She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice. Testosterone is also sometimes used without formal approval to treat reduced desire in females, although it is not officially approved for it. But in addition to drugs, doctors say that personal habits should also be considered. Conversations about libido almost always start with partnership dynamics and closeness. “I am comfortable recommending Addyi 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. Other suggestions for increasing sexual desire include: getting more sleep exercising maintaining an active lifestyle using over-the-counter personal lubricants engaging in extended intimate stimulation incorporating sexual wellness devices or vaginal dilators “You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “That means understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”