🔗 Share this article U.S. Food and Drug Administration Grants Approval to Flibanserin, a Desire-Boosting Drug for Women After Menopause Addyi, sometimes referred to as “the women's Viagra,” is now approved for use to combat diminished libido in females beyond reproductive age. The agency widened the authorized use of flibanserin, a daily drug to treat hypoactive sexual desire disorder (HSDD) in women, to include postmenopausal women up to age 65. This decision will open up fresh choices for older women, but specialists warn that treating low libido requires a “comprehensive strategy.” The medication carries serious risks with alcohol that may lead to loss of consciousness, so avoiding alcoholic beverages is essential. U.S. regulators widened the indication of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to 65 years old. Before the announcement, the pill, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age. Flibanserin was originally authorized by the FDA in 2015, following a lengthy and contentious review process. The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency cited issues about safety, efficacy, and an concerning balance of risks and benefits. Today, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019. The chief executive of the maker of Addyi applauded the FDA’s action to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health. Additional specialists in female health were supportive for the regulatory move. “I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be very important 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 “quite reasonable” given the existing research. Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?” Understanding Flibanserin, the ‘Women's Desire Pill’? Flibanserin, which is often called “female Viagra,” has little in common with the medication from which it gets its informal name. The drug was first created as an antidepressant but was found to be lacking during initial trials. Nevertheless, researchers observed improvements in aspects of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire. After two rejections, Addyi was cleared in 2015 to treat HSDD, following further studies and a major lobbying effort. The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol. Official guidance advises allowing a two-hour gap after consuming alcohol before taking the drug to reduce the chance of syncope. If a person has several drinks on a single occasion, the instructions advises skipping the dose entirely. Claims about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research investigating the interaction. The research, which were small in scale, demonstrated no increased danger of fainting. 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 aren’t very long,” a public health expert stated. An OB-GYN suggested that this may have been part of the cause why the drug was not originally approved for older females. “Patients have experienced side effects like the syncopal episodes and dizziness especially in persons 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 limited at age 65. “I don’t know if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, 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 Diminished Sexual Desire in Postmenopausal Women Despite these risks, flibanserin could still broaden treatment options for low desire to a different group 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 specialist. But it is not a quick fix. In fact, the experts interviewed all agreed that the female libido is complex and multifaceted. So treating HSDD means engaging with everything from partnership issues to hormonal changes. Women after menopause experience a broad range of symptoms that can impact sexual desire. Symptoms of menopause include: hot flashes vaginal dryness 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 concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said. The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the symptoms of menopause, particularly dryness. She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a viable choice. Androgen therapy is also occasionally prescribed off-label to address low libido in women, although it is not officially approved for it. But besides medication, doctors say that personal habits should also be factored in. Conversations about libido almost always begin by focusing on partnership dynamics and closeness. “I would have no problem recommending Addyi after discussing it 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 include: improving sleep hygiene exercising maintaining an active lifestyle applying over-the-counter personal lubricants practicing extended intimate stimulation using vibrators or vaginal dilators “It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”