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The federal agency expanded its approval of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

Before this week's decision, the drug, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In both cases, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s action to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional specialists in female health were supportive for the decision.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be very important to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “logical” 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 magnitude of the benefit is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

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

The drug was initially researched as an medication for depression but was deemed ineffective during initial trials.

However, scientists observed improvements in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

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

Addyi carries a boxed (“black box”) warning for serious side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance recommends waiting at least two hours after drinking before using Addyi to minimize the risk of syncope. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the maker to fund further research investigating the combination. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“These studies aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

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

“There have been side effects like the syncopal episodes and dizziness 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.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for HSDD to a different group of females who may benefit.

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

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

Postmenopausal females navigate a wide variety of changes that can impact sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

According to one expert, managing these issues is often a first step toward sexual wellness.

“If somebody came to me with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

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

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

But besides medication, doctors say that personal habits should also be considered. Discussions about libido almost always start with partnership dynamics and closeness.

“I am comfortable 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 boosting sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in older age,” said an expert. “This involves 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 climax of orgasm.”