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The federal agency broadened the authorized use of a once-a-day medication to manage low libido in women to now encompass postmenopausal women up to the age of sixty-five.

Prior to the announcement, the medication, flibanserin (Addyi), was solely authorized to address low sexual desire in women of reproductive age.

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health expressed support for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “understandable” given the existing research.

While in favor, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

Nevertheless, researchers noted positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a major lobbying effort.

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before taking the drug to minimize the risk of fainting. If a person has three or more alcoholic drinks on a given day, the label advises skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“This research aren't very convincing 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 speculated that this may have been part of the cause why the drug was not originally approved for older females.

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

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

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, 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.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for low desire to a new population of females who may find help.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an specialist.

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

So treating HSDD means considering everything from relationship dynamics to shifts in hormone levels.

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, treating these symptoms is often a initial approach toward improved intimacy.

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

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

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in women, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be considered. Conversations about libido almost always start with relationships and intimacy.

“I would have no problem prescribing Addyi after having a conversation 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 are:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an expert. “That means understanding how your body works, your anatomy, 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.”