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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to address low libido in females to include postmenopausal women up to age 65.

Before the recent news, the medication, flibanserin (Addyi), was solely authorized to address low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in 2015, following a protracted and controversial review process.

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

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

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

Additional OB-GYNs were supportive for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be very important to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “understandable” given the existing research.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the improvement is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was first created as an antidepressant but was deemed ineffective during initial trials.

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

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

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

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund further research examining the combination. The research, which were limited in size, demonstrated no additional risk of syncope. But experts had reservations.

“These studies aren't very persuasive to me. They are a beginning, 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 the drug was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in individuals 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 expressed uncertainty about why the broader approval was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for low desire to a different group of women who may benefit.

“I do think it will serve 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 experts consulted universally acknowledged that the female libido is complex and multifaceted.

So addressing HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

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

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

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

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a treatment option.

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

But in addition to drugs, experts say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem prescribing Addyi 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 suggestions for boosting libido are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or dilators

“It requires an entire whole body approach to sexuality and menopause in older age,” said an expert. “That means understanding how your body works, your physiology, 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.”