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The federal agency broadened the authorized use of a once-a-day medication to manage low libido in females to now encompass women after menopause up to 65 years old.

Prior to the announcement, the medication, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

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

“I had few tools 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 significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “understandable” given the clinical evidence.

Although supportive, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

This medication was initially researched as an medication for depression but was deemed ineffective during initial trials.

However, researchers noted improvements in measures of sexual function and shifted focus to the drug’s possible use as a treatment for low libido.

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

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

The label advises allowing a two-hour gap after drinking before using the drug to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the maker to fund further research investigating the interaction. The studies, which were small in scale, demonstrated no increased danger of fainting. But experts had reservations.

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

An gynecologist suggested that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at age 65.

“It's unclear if that has to do with the intricacies of the medication. If you take 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 prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

“I do think it will benefit this population better as long as they have no other medical problems,” said an OB-GYN.

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

So treating HSDD means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a broad range of changes that can affect libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

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

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to treat reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending flibanserin 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 suggestions for boosting sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended foreplay
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” 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 excited, and ultimately to have a peak of sexual pleasure.”