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U.S. regulators broadened the authorized use of a once-a-day medication to address low libido in women to include postmenopausal women up to the age of sixty-five.

Before the announcement, the drug, flibanserin (Addyi), was only approved to address low sexual desire in women of reproductive age.

The drug was first approved by the FDA in two thousand fifteen, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Additional specialists in female health voiced approval for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “logical” given the available data.

Although supportive, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

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

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

However, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following additional research and a considerable lobbying effort.

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

Official guidance advises waiting at least two hours after drinking before using the drug to minimize the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the maker to fund additional studies examining the interaction. The studies, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

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

“There have been adverse reactions like the fainting spells 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 things like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

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

“I do think it will benefit this population better as long as they have no other health issues,” said an OB-GYN.

But it is not a simple solution. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors.

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

Women after menopause experience a broad range of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, managing these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a treatment option.

Androgen therapy is also sometimes used without formal approval to address reduced desire in females, although it is not indicated for it.

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

“I am comfortable recommending flibanserin 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 boosting libido include:

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

“It requires an entire whole body approach to sexual health and this life stage in later life,” 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 excited, and ultimately to have a peak of orgasm.”