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U.S. regulators broadened the authorized use of a once-a-day medication to address low libido in females to cover women after menopause up to the age of sixty-five.

Prior to this week's decision, the medication, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.

Flibanserin was first approved by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA raised concerns about its safety profile, effectiveness, 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 as-needed injectable treatment, in 2019.

The founder and CEO of the maker of Addyi commended the FDA’s move to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs voiced approval for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be crucial to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

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

While in favor, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

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

Addyi, which is often called “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

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

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

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a significant advocacy campaign.

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

Official guidance recommends allowing a two-hour gap after consuming alcohol before using Addyi to minimize the risk of fainting. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had reservations.

“These studies aren't very convincing 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 speculated that this may have been part of the reason why the drug was not initially cleared for older females.

“There have been side effects like the fainting spells and dizziness especially in persons who have had an drink 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 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a new population of females who may find help.

“I do think it will serve this population better as long as they have no other medical problems,” said an specialist.

But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

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

Women after menopause experience a broad range of symptoms that can impact sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to treat the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less concerned about it and to consider it as a viable choice.

Testosterone is also sometimes used without formal approval to address reduced desire in females, although it is not indicated for it.

But besides medication, experts say that personal habits should also be considered. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending 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.

Additional suggestions for increasing sexual desire include:

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

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “That means 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 sexual pleasure.”