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U.S. regulators widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to 65 years old.

Prior to this week's decision, the medication, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

The drug was first approved by the FDA in 2015, following a protracted and controversial review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the maker of flibanserin praised the FDA’s move to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Other OB-GYNs were supportive for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be very important to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding 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 drug from which it gets its informal name.

The drug was first created as an medication for depression but was considered unsuccessful during initial trials.

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

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

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

The label advises allowing a two-hour gap after drinking before taking the drug to minimize the chance of fainting. If a person has several drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the combination. The research, which were limited in size, demonstrated no additional risk of syncope. But experts had concerns.

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

An gynecologist speculated that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“There have been side effects like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, 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.

Addressing Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand treatment options for low desire to a different group of women who may find help.

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

But it is not a simple solution. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause navigate a wide variety of symptoms that can affect libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

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

Androgen therapy is also sometimes prescribed off-label to treat reduced desire in women, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be factored in. Conversations about sexual desire almost always start with relationships and intimacy.

“I would have no problem prescribing flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting libido are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “This involves understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”