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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to address low libido in females to cover women after menopause up to age 65.

Before the announcement, the pill, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was initially cleared by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the agency raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s move to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs voiced approval for the decision.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be very important to address women after menopause who wish to engage in 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 cautious in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not overwhelming. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was found to be lacking during initial trials.

Nevertheless, researchers observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to minimize the chance of fainting. If a person consumes several drinks on a given day, the label recommends skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually prompted the maker to fund further research examining the interaction. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had reservations.

“These studies aren't 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 gynecologist suggested that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“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 susceptible to things like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at 65 years of age.

“It's unclear if that has to do with the complexity 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 clearer instructions because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

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

“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 magic bullet. In fact, the specialists consulted all agreed that the female libido is influenced by many factors.

So treating low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a broad range of changes that can impact sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? 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 dryness.

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

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

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

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “That means 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 climax of sexual pleasure.”