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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to 65 years old.

Before the recent news, the medication, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

Additional OB-GYNs voiced approval for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “quite reasonable” given the clinical evidence.

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

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

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it draws its nickname.

The drug was first created as an medication for depression but was deemed ineffective during early studies.

However, scientists noted improvements in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label recommends allowing a two-hour gap after drinking before taking Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the maker to fund further research investigating the interaction. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had concerns.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

An gynecologist suggested that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

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

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

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a different group of females who may benefit.

“I believe it will serve 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 experts consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So treating low desire means considering everything from relationship dynamics to hormonal changes.

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

As noted by one expert, treating these issues is often a initial approach toward sexual wellness.

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as options to alleviate the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also occasionally used without formal approval to address low libido in females, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on 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.

Additional recommendations for boosting sexual desire are:

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

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “That means knowing 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.”