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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to age 65.

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

The drug was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA 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 Addyi praised the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Other specialists in female health 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 obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “quite reasonable” given the available data.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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 medication from which it draws its nickname.

The drug was first created as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists observed improvements in measures of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for serious side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the label advises not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually prompted the maker to fund additional studies examining the interaction. The research, which were limited in size, showed no additional risk of syncope. But medical professionals had reservations.

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

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“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 sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Despite these risks, Addyi could still broaden treatment options for low desire to a new population of women who may benefit.

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

But it is not a quick fix. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

So treating low desire means considering everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of changes that can impact sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

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

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

“I am comfortable prescribing Addyi 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.

Other suggestions for boosting sexual desire are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an expert. “This involves understanding 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 climax of orgasm.”