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The federal agency broadened the authorized use of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to age 65.

Prior to this week's decision, the medication, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a protracted and controversial evaluation period.

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

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the maker of Addyi praised the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional OB-GYNs were supportive for the decision.

“I had few tools 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 patient population could be very important to address postmenopausal women who wish to engage in 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 clinical evidence.

Although supportive, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the enhancement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was originally developed as an antidepressant but was deemed ineffective during initial trials.

However, researchers observed improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

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

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance advises waiting at least two hours after drinking before using the drug to minimize the chance of syncope. If a person consumes several drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns.

“This research aren't very persuasive to me. They are a beginning, 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 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 treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at 65 years of age.

“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, it’s really wide-ranging. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

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 demographic better as long as they have no other health issues,” said an specialist.

But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

So addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause navigate a wide variety of symptoms that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• 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 initial inquiry is: How’s your vagina feeling? 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 hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also occasionally prescribed off-label to address low libido in women, 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 begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending flibanserin 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 increasing libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexuality and this life stage in older age,” 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 aroused, and ultimately to have a peak of orgasm.”