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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to manage low libido in women to cover women after menopause up to 65 years old.

Before the announcement, the pill, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in premenopausal females.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Other women’s health experts voiced approval for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be significant to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “logical” given the existing research.

Although supportive, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Flibanserin, which is sometimes referred to as “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.

Nevertheless, researchers noted improvements in measures of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to minimize the risk of syncope. If a person has several drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually led the maker to fund further research investigating the combination. The research, which were limited in size, showed no increased danger of syncope. But experts had concerns.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a public health expert stated.

An gynecologist speculated that this may have been part of the reason why the drug was not originally approved for older females.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped at age 65.

“It's unclear if that has to do with the complexity of the medication. Reviewing 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 clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

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

“I believe it will serve this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a simple solution. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of changes that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

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

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

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

Androgen therapy is also sometimes prescribed off-label to address reduced desire in females, although it is not indicated for it.

But besides medication, experts say that personal habits should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending flibanserin after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for boosting sexual desire are:

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

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an expert. “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 excited, and ultimately to have a climax of sexual pleasure.”