🔗 Share this article FDA Approves Flibanserin, a Desire-Boosting Drug for Females Beyond Menopause Flibanserin, often called “female Viagra,” is now approved for use to address low sex drive in postmenopausal women. The FDA expanded its approval of flibanserin, a oral medication to address hypoactive sexual desire disorder (HSDD) in women, to encompass postmenopausal women up to age 65. This decision will provide additional therapeutic avenues for this demographic, but specialists warn that treating low libido requires a “holistic method.” The medication carries potentially dangerous interactions with drinking that may lead to loss of consciousness, so avoiding alcoholic beverages is essential. The federal agency broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to the age of sixty-five. Prior to this week's decision, the pill, Addyi (flibanserin), was only approved 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 lengthy and contentious regulatory scrutiny. The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA raised concerns about safety, effectiveness, and an concerning balance of risks and benefits. Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen. The founder and CEO of the maker of flibanserin commended the FDA’s action to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health. Additional OB-GYNs voiced approval for the decision. “Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be very important to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.” A clinical professor told reporters that the approval was “quite reasonable” given the clinical evidence. Although supportive, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the improvement is not overwhelming. Does it justify taking a drug daily and not experiencing a dramatic change?” Understanding Addyi, the ‘Female Viagra’? Addyi, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it gets its informal name. The drug was initially researched as an medication for depression but was considered unsuccessful during early studies. However, researchers observed improvements in aspects of sexual function and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire. Following initial denials, Addyi was cleared in 2015 to treat HSDD, following further studies and a significant lobbying effort. The medication carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol. Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the label advises not taking the pill 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 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 big and certainly are short-term,” 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 older females. “Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to things 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 intricacies of the medication. 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 clearer instructions because it may affect our clinical decisions,” he said. Addressing Low Libido in Postmenopausal Women Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a new population of women who may find help. “I do think it will serve this population 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 all agreed that the female libido is influenced by many factors. So addressing low desire means considering everything from partnership issues to shifts in hormone levels. Postmenopausal females navigate a broad range of changes that can affect sexual desire. Symptoms of menopause encompass: sudden feelings of heat lack of natural lubrication pain during intercourse sleep disturbances bladder leakage As noted by one expert, treating these symptoms is often a first step toward improved intimacy. “When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said. The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the symptoms of menopause, particularly vaginal dryness. She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a treatment option. Androgen therapy is also sometimes used without formal approval to address reduced desire in women, although it is not indicated for it. But besides medication, experts say that lifestyle should also be considered. Conversations about libido almost always start with relationships and intimacy. “I would have no problem recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said. Additional recommendations for increasing libido include: improving sleep hygiene engaging in physical activity staying active using over-the-counter personal lubricants engaging in extended foreplay using sexual wellness devices or vaginal dilators “You have to take an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “That means knowing 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 peak of sexual pleasure.”