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The federal agency broadened the authorized use of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Before the announcement, the drug, flibanserin (Addyi), was only approved to treat low sexual desire in women of reproductive age.

This medication was originally authorized by the FDA in 2015, following a long and debated review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

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

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional OB-GYNs voiced approval for the decision.

“I had few tools for me to prescribe 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 help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the benefit is not overwhelming. Does it justify taking a drug daily and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

The drug was initially researched as an antidepressant but was found to be lacking during early studies.

However, researchers noted positive changes in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before using Addyi to minimize the risk of fainting. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

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

An gynecologist suggested 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 lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was capped at age 65.

“It's unclear if that has to do with the intricacies of the medication. If you take 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 simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a different group of women who may benefit.

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

But it is not a quick fix. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a wide variety of changes that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, managing these issues is often a initial approach 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 suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly vaginal dryness.

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

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

But besides medication, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“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 are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “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 aroused, and ultimately to have a peak of sexual pleasure.”