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U.S. regulators broadened the authorized use of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to 65 years old.

Before this week's decision, the medication, Addyi (flibanserin), was solely authorized to address low sexual desire in premenopausal females.

The drug was first approved by the FDA in 2015, following a lengthy and contentious review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

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

The founder and CEO of the maker of Addyi praised the FDA’s move to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs voiced approval for the decision.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance 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 “understandable” given the existing research.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the improvement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was found to be lacking during early studies.

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

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

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

Official guidance advises allowing a two-hour gap after drinking before using the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the effects 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 fainting. But experts had reservations.

“This research aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for older females.

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

Another doctor echoed uncertainty about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a new population of females who may benefit.

“I do think 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 interviewed universally acknowledged that the female libido is complex and multifaceted.

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

Women after menopause experience a broad range of symptoms that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

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

Testosterone is also occasionally used without formal approval to treat reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable prescribing 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 recommendations for boosting sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended foreplay
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an expert. “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 sexual pleasure.”