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The federal agency widened the indication of a once-a-day medication to address low libido in females to cover women after menopause up to age 65.

Before the announcement, the pill, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a lengthy and contentious review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the maker of flibanserin praised the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Other specialists in female health expressed support for the decision.

“I had few tools for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “understandable” given the existing research.

While in favor, 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 benefit is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

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 initially researched as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before taking Addyi to reduce the risk of fainting. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

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

“Patients have experienced adverse reactions like the syncopal episodes 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 capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. If you take 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 After Menopause

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a different group of females who may benefit.

“I do think it will serve 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 female libido is influenced by many factors.

So treating low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a wide variety of changes that can impact sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with libido issues, my initial inquiry 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 treat the symptoms of menopause, particularly dryness.

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

Androgen therapy is also occasionally prescribed off-label to address low libido in women, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about libido almost always start with partnership dynamics and closeness.

“I am comfortable prescribing Addyi 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 recommendations for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “That means understanding how your body works, your anatomy, 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.”