🔗 Share this article U.S. Food and Drug Administration Grants Approval to Addyi, a Libido-Enhancing Medication for Women After Menopause Flibanserin, often called “female Viagra,” is now cleared for treatment to treat diminished libido in women after menopause. Regulators broadened the indication of Addyi, a daily drug to treat low libido in women, to include women after menopause up to age 65. The approval will unlock new treatment options for older women, but experts caution that treating low libido requires a “holistic method.” Addyi is known to have potentially dangerous interactions with alcohol that may cause loss of consciousness, so avoiding alcoholic beverages is essential. The federal agency broadened the authorized use of a daily pill to address low libido in women to include women after menopause up to 65 years old. Prior to the announcement, the drug, 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 2015, following a protracted and controversial review process. The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile. Currently, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019. The chief executive of the pharmaceutical company of Addyi applauded the FDA’s action to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness. Additional women’s health experts voiced approval for the regulatory move. “Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.” A clinical professor told reporters that the approval was “quite reasonable” given the existing research. While in favor, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?” Understanding Flibanserin, the ‘Women's Desire Pill’? Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname. This medication was originally developed as an medication for depression but was deemed ineffective during initial trials. Nevertheless, researchers observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido. After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign. The medication carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks. Official guidance recommends waiting at least two hours after drinking before using Addyi to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely. Assertions about the effects of combining the drug with drinking eventually led the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. 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 public health expert stated. An OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for postmenopausal women. “Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said. Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age. “I don’t know if that has to do with the intricacies 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 simpler guidance because it may affect our prescribing,” he said. Treating Diminished Sexual Desire in Postmenopausal Women Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a new population of females who may find help. “I believe it will benefit this population better as long as they have no other medical problems,” said an OB-GYN. But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors. So treating low desire means engaging with everything from partnership issues to shifts in hormone levels. Postmenopausal females navigate a wide variety of changes that can affect sexual desire. Menopausal symptoms include: hot flashes lack of natural lubrication discomfort with sex insomnia urinary incontinence According to one expert, treating these issues is often a initial approach toward sexual wellness. “When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said. The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate 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 concerned about it and to view it as a treatment option. Testosterone is also sometimes prescribed off-label to treat low libido in women, although it is not officially approved for it. But in addition to drugs, experts say that personal habits should also be factored in. Conversations about libido almost always start with relationships and intimacy. “I am comfortable recommending flibanserin 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. Additional suggestions for increasing libido are: getting more sleep engaging in physical activity staying active applying over-the-counter personal lubricants practicing extended intimate stimulation incorporating vibrators or vaginal dilators “It requires an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “That means knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”