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The federal agency broadened the authorized use of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

Prior to the recent news, the medication, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

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

“There was nothing for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to help postmenopausal women who want to have 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 clinical evidence.

While in favor, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

This medication was first created as an antidepressant but was deemed ineffective during early studies.

Nevertheless, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before taking the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research examining the combination. The research, which were small in scale, showed no increased danger of fainting. But medical professionals had concerns.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An gynecologist suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was capped 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 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

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a different group 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 OB-GYN.

But it is not a simple solution. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors.

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

Women after menopause experience a broad range of changes that can affect sexual desire. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“When a patient presents 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 systemic hormone therapy as treatments 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 concerned about it and to view it as a treatment option.

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

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

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

Other recommendations for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• 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 later life,” said an OB-GYN. “This involves 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 climax of orgasm.”