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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to manage low libido in women to now encompass postmenopausal women up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was initially cleared by the FDA in 2015, following a lengthy and contentious review process.

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

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

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s move to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs were supportive for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the existing research.

While in favor, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was first created as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, scientists noted positive changes in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after drinking before taking Addyi to reduce the risk of syncope. If a person consumes several drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research investigating the interaction. The research, which were limited in size, showed no increased danger of syncope. But medical professionals had reservations.

“These studies don’t seem 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 reason why the drug was not initially cleared for postmenopausal women.

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

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

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the instructions and restrictions, they are extensive. 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 Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a new population of females who may find help.

“I do think it will serve 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 consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing HSDD means considering everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of symptoms that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• 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 recommended both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly vaginal 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 view it as a treatment option.

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

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about libido 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 psychosocial issues going on,” she said.

Additional suggestions for increasing 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 vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”