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U.S. regulators 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 age 65.

Before the recent news, the medication, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

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

Other OB-GYNs were supportive for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women 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 clinical professor told news outlets that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was originally developed as an medication for depression but was deemed ineffective during initial trials.

However, researchers observed improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person consumes several drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, which were limited in size, demonstrated no additional risk of fainting. But experts had reservations.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An gynecologist suggested that this may have been part of the reason why the drug was not initially cleared for older females.

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor expressed 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. If you take 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 prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

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

“I believe it will benefit 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 complex and multifaceted.

So addressing low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a broad range of symptoms that can affect libido. Menopausal symptoms include:

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

According to one expert, treating these symptoms is often a first step toward sexual wellness.

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

The expert recommended both vaginal estrogen and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a viable choice.

Testosterone is also sometimes prescribed off-label to treat reduced desire in females, although it is not indicated for it.

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

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

Other suggestions for boosting libido are:

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

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” 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 excited, and ultimately to have a peak of sexual pleasure.”