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U.S. regulators widened the indication of a daily pill to manage low libido in females to include postmenopausal women up to 65 years old.

Prior to the recent news, the drug, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was first approved by the FDA in two thousand fifteen, following a long and debated evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Other specialists in female health were supportive for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “understandable” given the clinical evidence.

Although supportive, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

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

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was originally developed as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, scientists noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for low libido.

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

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label advises waiting at least two hours after drinking before taking Addyi to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the maker 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 don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An gynecologist suggested 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 lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. Reviewing 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 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 different group of females who may find help.

“I believe it will serve this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.

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

Women after menopause navigate a broad range of symptoms that can impact sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

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

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” 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 FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a treatment option.

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

But besides medication, doctors say that lifestyle should also be factored in. Conversations about libido almost always start with relationships and intimacy.

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

Other recommendations for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and this life stage in older age,” said an expert. “That means knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of orgasm.”