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U.S. regulators widened the indication of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to 65 years old.

Prior to the recent news, the drug, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was first approved by the FDA in 2015, following a long and debated 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 its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s action to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other women’s health experts voiced approval for the decision.

“There was nothing for me to recommend because available treatments 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 postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “logical” given the available data.

Although supportive, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

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

Flibanserin, which is often called “female Viagra,” has few similarities with the medication from which it draws its nickname.

This medication was initially researched as an antidepressant but was found to be lacking during early studies.

However, researchers noted positive changes in aspects of sexual function and redirected efforts to the drug’s possible use as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

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

Official guidance advises waiting at least two hours after drinking before using Addyi to minimize the risk of fainting. If a person has three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research investigating the interaction. The studies, which were small in scale, showed no additional risk of syncope. But experts had concerns.

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

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells 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 things like that,” she said.

Another doctor echoed uncertainty about why the broader approval was limited 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 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 Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a different group of females who may benefit.

“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 magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a wide variety of changes that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these symptoms is often a first step toward sexual wellness.

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

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

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

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

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

“I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “This involves understanding how your body works, your physiology, 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.”