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The Food and Drug Administration (FDA) widened the indication of a oral treatment to address hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to age 65.

Before the recent news, the drug, 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 protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs expressed support for the decision.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not getting bang for your buck?”

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

Flibanserin, which is sometimes referred to as “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 found to be lacking during early studies.

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

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a major advocacy campaign.

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

Official guidance recommends waiting at least two hours after consuming alcohol before using the drug to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the maker to fund further research investigating the combination. The studies, which were limited in size, demonstrated no increased danger of fainting. But experts had concerns.

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

An OB-GYN suggested 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 fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still broaden treatment options for HSDD to a new population of women who may find help.

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

But it is not a magic bullet. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted.

So treating HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause navigate a wide variety of symptoms that can impact libido. Symptoms of menopause include:

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

As noted by one expert, managing these issues is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a viable choice.

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

But besides medication, doctors say that personal habits should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending flibanserin after discussing it 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 are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended foreplay
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “This involves understanding how your body works, your anatomy, 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 orgasm.”