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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to 65 years old.

Before the recent news, the drug, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

This medication was first approved by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

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

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

Additional OB-GYNs expressed support for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be very important to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “logical” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the enhancement is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

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

The drug was first created as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, researchers observed improvements in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

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

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

Official guidance advises waiting at least two hours after consuming alcohol before using the drug to reduce the risk of fainting. If a person consumes several drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had reservations.

“These studies aren't very persuasive 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 gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared 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 taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. 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 simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a new population of women who may benefit.

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

But it is not a magic bullet. 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 hormonal changes.

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

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a first step toward improved intimacy.

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

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

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.

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

But in addition to drugs, experts say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending flibanserin 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 recommendations for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”