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The federal agency broadened the authorized use of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to the age of sixty-five.

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

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 2013. In both cases, the FDA cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s decision to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other specialists in female health expressed support for the decision.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the enhancement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was first created as an medication for depression but was found to be lacking during initial trials.

However, researchers noted positive changes in measures of libido and arousal and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following additional research and a considerable lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

The label recommends waiting at least two hours after drinking before using the drug to reduce the risk of syncope. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the effects of mixing the drug with drinking eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were limited in size, showed no increased danger of fainting. But experts had reservations.

“These studies aren't very convincing to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert 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 syncopal episodes and dizziness especially in individuals 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 expressed uncertainty about why the broader approval was limited at age 65.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, it’s really wide-ranging. 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 Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand treatment options for low desire to a new population of females who may find help.

“I do think it will serve this population better as long as they have no other medical problems,” said an specialist.

But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

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

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

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

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

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

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also occasionally used without formal approval to address reduced desire in women, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for increasing sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”