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The federal agency widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to 65 years old.

Before the announcement, the pill, flibanserin (Addyi), was only approved to address low sexual desire in women of reproductive age.

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 agency expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the maker of flibanserin applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” 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 menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be significant to address women after menopause 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 approval was “quite reasonable” given the existing research.

While in favor, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities 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.

Nevertheless, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before taking the drug to reduce the risk of syncope. If a person has three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The studies, which were small in scale, showed no increased danger of syncope. But experts had reservations.

“These studies aren't 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 suggested that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“There have been adverse reactions like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage 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 confusion about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for low desire to a new population of women who may benefit.

“I believe it will serve this population better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing HSDD means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a broad range of symptoms that can impact libido. Menopausal symptoms encompass:

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

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

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for boosting sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in older age,” said an expert. “That means understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”