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The Food and Drug Administration (FDA) expanded its approval of a daily pill to address low libido in women to cover women after menopause up to age 65.

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

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional women’s health experts were supportive for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be crucial 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 decision was “understandable” given the available data.

While in favor, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

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

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

Nevertheless, researchers noted positive changes in measures of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance recommends allowing a two-hour gap after drinking before using the drug to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually prompted the maker to fund further research examining the combination. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had concerns.

“These studies aren't very persuasive to me. They are a good start, 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.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in individuals 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 confusion about why the broader approval was capped at age 65.

“I don’t know 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 cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

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

“I believe 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 women's sexual desire is influenced by many factors.

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

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She hopes 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 consider it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to treat low libido in women, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable prescribing Addyi 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 suggestions for boosting libido are:

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

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “That means knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”