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U.S. regulators expanded its approval of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to 65 years old.

Prior to the recent news, the pill, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

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

The chief executive of the maker of flibanserin commended the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional OB-GYNs voiced approval for the regulatory move.

“I had few tools for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “logical” given the existing research.

Although supportive, the expert was guarded in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the benefit is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

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

This medication was first created as an antidepressant but was deemed ineffective during early studies.

However, scientists observed positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following further studies and a major advocacy campaign.

Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to minimize the chance of syncope. If a person has several drinks on a given day, the label advises skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually led the maker to fund further research examining the interaction. The research, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

“These studies aren't very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

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

Another doctor expressed uncertainty about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, they are extensive. 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, Addyi could still expand treatment options for low desire to a new population of women who may find help.

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

But it is not a simple solution. In fact, the experts consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

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

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these symptoms is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my first question 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 alleviate the symptoms of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less concerned about it and to view it as a viable choice.

Testosterone is also occasionally prescribed off-label to address reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem prescribing Addyi after having a conversation 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 boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an expert. “This involves knowing how your body works, your physiology, 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 sexual pleasure.”