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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 females to include women after menopause up to the age of sixty-five.

Prior to the recent news, the drug, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age.

This medication was originally authorized by the FDA in 2015, following a long and debated evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

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

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Other OB-GYNs expressed support for the decision.

“Previously, options were limited 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 patient population could be crucial to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the available data.

While in favor, the expert was guarded in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not dramatic. Does it justify taking a drug daily and not getting bang for your buck?”

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

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

This medication was originally developed as an antidepressant but was considered unsuccessful during initial trials.

However, scientists observed improvements in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

Official guidance recommends allowing a two-hour gap after drinking before taking the drug to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the label advises not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The research, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations.

“These studies don’t seem very convincing to me. They are a good start, but they’re not very large-scale 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 the drug was not originally approved for older females.

“There have been adverse reactions like the syncopal episodes and lightheadedness 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 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 intricacies of the drug. If you take a list of the instructions and restrictions, 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.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand therapeutic choices for low desire to a new population 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 OB-GYN.

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

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

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

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

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

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a viable choice.

Testosterone is also occasionally prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be factored in. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for boosting libido are:

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

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “That means understanding 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 orgasm.”