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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to address low libido in females to cover women after menopause up to the age of sixty-five.

Prior to this week's decision, the pill, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other women’s health experts expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “logical” given the clinical evidence.

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the enhancement is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it gets its informal name.

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

However, researchers observed improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

Addyi carries a serious safety warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

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

Claims about the effects of mixing Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had concerns.

“These studies don’t seem very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for older females.

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty 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 drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a new population of women who may benefit.

“I do think it will benefit this demographic better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the specialists consulted all agreed that the female libido is complex and multifaceted.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a broad range of symptoms that can affect libido. Menopausal symptoms encompass:

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

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

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to view it as a viable choice.

Testosterone is also sometimes prescribed off-label to address reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts 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 recommending 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.

Additional suggestions for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” 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 orgasm.”