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U.S. regulators widened the indication of a once-a-day medication to treat low libido in women to cover women after menopause up to the age of sixty-five.

Before this week's decision, the medication, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In both cases, the agency raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Currently, 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 chief executive of the pharmaceutical company of flibanserin commended the FDA’s move to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional women’s health experts were supportive for the regulatory move.

“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 group of women could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “logical” given the existing research.

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

Understanding Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

The drug was first created as an antidepressant but was considered unsuccessful during initial trials.

However, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

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

Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund additional studies examining the combination. The research, which were small in scale, showed no additional risk of fainting. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale 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.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age.

“It's unclear 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 approved, they need to come out with an simpler guidance 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 HSDD to a new population of women who may benefit.

“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 simple solution. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a wide variety of changes that can impact sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, treating these symptoms is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes used without formal approval to address low libido in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing 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.

Other suggestions for increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “That means understanding 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 sexual pleasure.”