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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 women to now encompass postmenopausal women up to 65 years old.

Before the announcement, the medication, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was first approved by the FDA in two thousand fifteen, 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 expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi 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 founder and CEO of the maker of flibanserin commended the FDA’s action to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional women’s health experts were supportive for the regulatory move.

“There was nothing 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 patient population could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “logical” given the existing research.

Although supportive, the expert was guarded in her assessment: “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 getting bang for your buck?”

Understanding Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it draws its nickname.

This medication was initially researched as an antidepressant but was considered unsuccessful during initial trials.

However, scientists observed improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

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

The label recommends waiting at least two hours after consuming alcohol before taking the drug to reduce the chance of syncope. If a person consumes several drinks on a given day, the instructions advises skipping the dose entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the interaction. The research, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had concerns.

“These studies aren't very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

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

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

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

“It's unclear if that has to do with the complexity of the drug. Reviewing a list of the instructions and restrictions, they are extensive. 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 Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a new population of females who may benefit.

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

But it is not a simple solution. In fact, the experts consulted all agreed that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a wide variety of changes that can impact sexual desire. Symptoms of menopause encompass:

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

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

“If somebody came to me 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 options to alleviate the effects of menopause, particularly dryness.

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

Androgen therapy is also occasionally used without formal approval to address low libido in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing libido include:

• getting more sleep
• engaging in physical activity
• 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 older age,” said an OB-GYN. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”