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U.S. regulators broadened the authorized use of a oral treatment to manage low libido in women to now encompass postmenopausal women up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.

The drug was initially cleared by the FDA in 2015, following a long and debated evaluation period.

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

Today, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional OB-GYNs expressed support for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be very important to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “understandable” given the available data.

While in favor, the expert was measured in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

What is Flibanserin, the ‘Women's Desire Pill’?

Addyi, which is often called “female Viagra,” has little in common with the medication from which it draws its nickname.

This medication was first created as an antidepressant but was considered unsuccessful during early studies.

However, researchers noted positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance recommends waiting at least two hours after drinking before using Addyi to minimize the chance of syncope. If a person consumes several drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had reservations.

“These studies aren't very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause why the drug was not initially cleared for older females.

“There have been side effects like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor expressed confusion about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

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

“I believe it will serve this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a simple solution. In fact, the specialists consulted all agreed that the women's sexual desire is complex and multifaceted.

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

Postmenopausal females navigate a broad range of changes that can impact libido. Symptoms of menopause encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, treating these issues is often a first step toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also sometimes used without formal approval to treat low libido in females, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be factored in. Discussions about sexual desire almost always start with relationships and intimacy.

“I am comfortable recommending flibanserin after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing sexual desire include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended foreplay
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an OB-GYN. “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 aroused, and ultimately to have a climax of sexual pleasure.”