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U.S. regulators widened the indication of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

Prior to the announcement, the medication, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

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

Today, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), 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 “significant step” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs voiced approval for the regulatory move.

“There was nothing for me to recommend because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

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

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not dramatic. Does it justify taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the medication from which it draws its nickname.

This medication was initially researched as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, scientists observed improvements in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a major advocacy campaign.

The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before using Addyi to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually led the maker to fund further research investigating the combination. The studies, which were limited in size, demonstrated no increased danger of syncope. But experts had concerns.

“These studies aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An gynecologist suggested that this may have been part of the reason why the drug was not initially cleared for older females.

“There have been side effects like the fainting spells and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor echoed confusion about why the broader approval was capped at age 65.

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a new population of women who may benefit.

“I do think it will benefit this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause navigate a broad range of changes that can affect libido. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, treating these symptoms is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “serious” 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 address reduced desire in females, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an expert. “This involves understanding how your body works, your physiology, 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 orgasm.”