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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to 65 years old.

Prior to the recent news, the drug, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was first approved by the FDA in 2015, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the maker of flibanserin applauded the FDA’s move to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to help postmenopausal women who want to have 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 clinical evidence.

While in favor, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the placebo, but the extent of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

The drug was originally developed as an medication for depression but was deemed ineffective during early studies.

Nevertheless, scientists noted positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

The medication carries a serious safety 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 taking the drug to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the effects of combining the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the combination. The studies, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big 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 Addyi was not initially cleared for older females.

“There have been adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at 65 years of age.

“It's unclear if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, it’s really wide-ranging. 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 Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for HSDD to a different group of women who may benefit.

“I believe it will benefit this population better as long as they have no other medical problems,” said an specialist.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the female libido is complex and multifaceted.

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

Women after menopause navigate a wide variety of symptoms that can affect libido. Menopausal symptoms include:

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

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

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

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

Testosterone is also occasionally used without formal approval to treat reduced desire in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Discussions about libido 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.

Additional suggestions for increasing libido include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “This involves knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”