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The federal agency broadened the authorized use of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to age 65.

Before the recent news, the pill, Addyi (flibanserin), was solely authorized to treat low sexual desire in women of reproductive age.

The drug was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

The agency had denied approval for 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 Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s move to expand the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional specialists in female health were supportive for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Addyi, the ‘Women's Desire Pill’?

Addyi, which is often called “female Viagra,” has little in common with the drug from which it draws its nickname.

The drug was initially researched as an antidepressant but was deemed ineffective during initial trials.

However, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

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

The medication carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund further research examining the combination. The studies, which were limited in size, demonstrated no additional risk of syncope. But experts had reservations.

“These studies aren't very convincing 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 speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at age 65.

“It's unclear 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 simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire 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 specialist.

But it is not a magic bullet. In fact, the specialists consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So treating low desire means considering everything from partnership issues to hormonal changes.

Postmenopausal females navigate a wide variety of changes that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, treating these symptoms is often a initial approach 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 suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice.

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

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

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

Additional suggestions for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or dilators

“It requires an entire whole body approach to sexual health and menopause in older age,” said an expert. “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 excited, and ultimately to have a peak of sexual pleasure.”