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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to address low libido in females to cover women after menopause up to age 65.

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

The drug was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s action to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “understandable” given the available data.

Although supportive, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the improvement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was initially researched as an antidepressant but was found to be lacking during initial trials.

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

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

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

The label recommends waiting at least two hours after consuming alcohol before using Addyi to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund additional studies examining the combination. The studies, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had reservations.

“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 speculated 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 syncopal episodes and dizziness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a different group of females who may benefit.

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

But it is not a simple solution. In fact, the experts consulted universally acknowledged that the female libido is complex and multifaceted.

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

Women after menopause navigate a broad range of changes that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also sometimes used without formal approval to address reduced desire in females, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be factored in. Conversations about libido almost always start with relationships and intimacy.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage 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 orgasm.”