🔗 Share this article FDA Approves Addyi, a Desire-Boosting Medication for Postmenopausal Addyi, colloquially known as “female Viagra,” is now cleared for treatment to address reduced sexual desire in females beyond reproductive age. Regulators broadened the indication of Addyi, a oral medication to address low libido in women, to include women after menopause up to age 65. This decision will unlock new treatment options for this demographic, but experts caution that treating low libido requires a “holistic method.” This drug presents potentially dangerous interactions with drinking that may cause syncope, so avoiding alcoholic beverages is strongly advised. U.S. regulators broadened the authorized use of a daily pill to manage low libido in women to include postmenopausal women up to 65 years old. Before this week's decision, the medication, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females. This medication was first approved by the FDA in 2015, following a protracted and controversial evaluation period. Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile. Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen. The chief executive of the pharmaceutical company of flibanserin commended the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health. Additional OB-GYNs voiced approval for the decision. “Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be significant to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.” A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the existing research. While in favor, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?” What is Addyi, the ‘Female Viagra’? Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname. This medication was first created as an medication for depression but was considered unsuccessful during early studies. Nevertheless, researchers observed improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido. Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign. The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks. The label advises allowing a two-hour gap after drinking before using Addyi to reduce the risk of fainting. If a person consumes several drinks on a single occasion, the label recommends skipping the dose entirely. Assertions about the effects of mixing the drug with drinking eventually prompted the maker to fund further research examining the combination. The studies, which were limited in size, demonstrated no increased danger of syncope. But experts had reservations. “This research don’t seem very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated. An gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women. “Patients have experienced side effects like the fainting spells and dizziness especially in individuals who have had an drink 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 expanded indication was limited at age 65. “I don’t know if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said. Treating Diminished Sexual Desire After Menopause Despite these risks, Addyi could still broaden treatment options for low desire to a different group of females who may benefit. “I do think it will benefit this demographic better as long as they have no other medical problems,” said an specialist. But it is not a magic bullet. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors. So addressing HSDD means considering everything from relationship dynamics to shifts in hormone levels. Women after menopause navigate a wide variety of symptoms that can affect sexual desire. Menopausal symptoms include: hot flashes lack of natural lubrication pain during intercourse sleep disturbances bladder leakage According to one expert, managing these symptoms is often a first step toward sexual wellness. “If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said. The expert suggested both vaginal estrogen and systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness. She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a viable choice. Androgen therapy is also sometimes used without formal approval to treat reduced desire in women, although it is not indicated for it. But besides medication, doctors say that personal habits should also be factored in. Discussions about libido almost always start with partnership dynamics and closeness. “I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said. Other recommendations for increasing sexual desire are: improving sleep hygiene engaging in physical activity staying active using over-the-counter lubricants practicing extended intimate stimulation using sexual wellness devices or vaginal dilators “It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “This involves knowing how your body works, your physiology, 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 sexual pleasure.”