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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to treat low libido in women to now encompass women after menopause up to 65 years old.

Prior to the announcement, the medication, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the maker of flibanserin praised the FDA’s move to expand the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Additional women’s health experts were supportive for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “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 experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “logical” given the existing research.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it gets its informal name.

This medication was originally developed as an medication for depression but was found to be lacking during early studies.

However, scientists noted improvements in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

Official guidance recommends allowing a two-hour gap after drinking before taking Addyi to reduce the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the maker to fund additional studies investigating the interaction. The research, which were limited in size, demonstrated no additional risk of syncope. But experts had reservations.

“This research aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“There have been side effects like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, 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 Low Libido After Menopause

Despite these risks, flibanserin could still broaden therapeutic choices for HSDD to a new population of females who may benefit.

“I do think it will benefit 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 consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can impact sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate 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 concerned about it and to consider it as a treatment option.

Androgen therapy is also occasionally prescribed off-label to treat low libido in women, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for boosting libido include:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause 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 excited, and ultimately to have a peak of sexual pleasure.”