🔗 Share this article

U.S. regulators expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to 65 years old.

Before the announcement, the pill, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was first approved by the FDA in 2015, following a long and debated review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In both cases, the agency raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s action to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional specialists in female health expressed support for the regulatory move.

“Previously, options were limited for me to recommend 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 significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the existing research.

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

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

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

Nevertheless, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after drinking before taking the drug to reduce the risk of fainting. If a person has several drinks on a single occasion, the label recommends skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually led the maker to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had concerns.

“This research aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for older females.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a new population of females who may find help.

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

But it is not a quick fix. In fact, the experts interviewed universally acknowledged that the female libido is influenced by many factors.

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

Women after menopause navigate a wide variety of symptoms that can impact libido. Symptoms of menopause include:

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

According to one expert, managing these symptoms is often a first step toward improved intimacy.

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

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat low libido in women, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be factored in. Discussions about libido almost always start with partnership dynamics and closeness.

“I would have no problem recommending flibanserin 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 sexual desire include:

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

“It requires an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “That means understanding 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 orgasm.”