🔗 Share this article U.S. Food and Drug Administration Grants Approval to Flibanserin, a Libido-Enhancing Treatment for Postmenopausal Flibanserin, sometimes referred to as “the women's Viagra,” is now cleared for treatment to combat diminished libido in postmenopausal women. The agency widened the authorized use of flibanserin, a oral medication to treat hypoactive sexual desire disorder (HSDD) in women, to encompass women after menopause up to age 65. This decision will unlock new treatment options for older women, but experts caution that treating low libido requires a “comprehensive strategy.” The medication carries serious risks with drinking that may lead to loss of consciousness, so abstinence from alcohol is recommended. The Food and Drug Administration (FDA) widened the indication of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to the age of sixty-five. Before the recent news, the drug, flibanserin (Addyi), was exclusively cleared to address low sexual desire in premenopausal females. Flibanserin was initially cleared by the FDA in 2015, following a protracted and controversial regulatory scrutiny. The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile. Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019. The chief executive of the maker of Addyi commended the FDA’s action 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. “There was nothing for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.” A professor of obstetrics and gynecology told news outlets that the decision was “logical” given the existing research. While in favor, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?” Understanding Addyi, the ‘Female Viagra’? Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname. The drug was originally developed as an medication for depression but was deemed ineffective during initial trials. However, scientists observed positive changes in aspects of sexual function and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire. Following initial denials, 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 severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol. The label advises waiting at least two hours after drinking before using Addyi to minimize the risk of syncope. If a person has several drinks on a given day, the label advises skipping the dose entirely. Claims about the interactions of combining the drug with drinking eventually led the maker to fund additional studies investigating the interaction. The studies, which were limited in size, demonstrated no additional risk of fainting. But experts had reservations. “This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated. An OB-GYN speculated 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 syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said. Another doctor echoed uncertainty about why the broader approval was limited at age 65. “It's unclear if that has to do with the intricacies of the drug. Reviewing 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 clearer instructions because it may affect our prescribing,” he said. Treating Low Libido After Menopause Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD to a different group of females who may benefit. “I believe 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 specialists interviewed universally acknowledged that the female libido is influenced by many factors. So addressing HSDD means engaging with everything from partnership issues to hormonal changes. Women after menopause navigate a wide variety of symptoms that can affect sexual desire. Symptoms of menopause include: sudden feelings of heat lack of natural lubrication discomfort with sex sleep disturbances bladder leakage According to one expert, managing 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 vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly vaginal 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 viable choice. Testosterone is also sometimes prescribed off-label to address reduced desire in females, although it is not officially approved for it. But besides medication, experts say that lifestyle should also be factored in. Discussions about libido almost always start with partnership dynamics and closeness. “I would have no problem 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. Additional recommendations for boosting libido are: improving sleep hygiene exercising staying active applying over-the-counter lubricants practicing extended intimate stimulation incorporating sexual wellness devices or vaginal dilators “You have to take an comprehensive, holistic strategy to sexual health and this life stage 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 climax of orgasm.”