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The federal agency widened the indication of a once-a-day medication to manage low libido in females to include postmenopausal women up to 65 years old.

Prior to this week's decision, the medication, flibanserin (Addyi), was solely authorized 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.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

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

Other women’s health experts were supportive for the decision.

“I had few tools for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be crucial 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 news outlets that the approval was “logical” given the available data.

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the improvement is not overwhelming. Does it justify 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 “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, scientists observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

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

The label advises allowing a two-hour gap after drinking before taking the drug to reduce the chance of syncope. If a person has several drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund further research examining the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

“This research don’t seem very convincing 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 gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor expressed uncertainty about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

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

“I do think it will benefit 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 specialists consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause experience a broad range of changes that can impact libido. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.

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

But in addition to drugs, experts say that personal habits should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

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

Other suggestions for boosting libido are:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “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.”