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U.S. regulators broadened the authorized use of a once-a-day medication to treat low libido in females to cover women after menopause up to age 65.

Before the recent news, the medication, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a protracted and controversial review process.

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

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts voiced approval for the decision.

“There was nothing 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 group of women could be very important 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 available data.

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, scientists noted improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous 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 consuming alcohol before using the drug to reduce the chance of syncope. If a person has three or more alcoholic 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 interaction. The studies, which were limited in size, demonstrated no additional risk of fainting. But experts had concerns.

“These studies don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

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

“There have been side effects like the syncopal episodes and dizziness especially in individuals 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 things like that,” she said.

Another doctor expressed confusion about why the broader approval was limited at age 65.

“It's unclear if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for HSDD to a different group of females who may find help.

“I believe 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 women's sexual desire is influenced by many factors.

So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a broad range of changes that can affect sexual desire. Menopausal symptoms encompass:

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

As noted by one expert, managing these issues is often a first step 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 topical estrogen therapy 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 females to feel less apprehensive about it and to consider it as a treatment option.

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

But besides medication, 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 prescribing 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 boosting libido include:

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

“It requires an entire whole body approach to sexuality and menopause in older age,” said an expert. “This involves understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”