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U.S. regulators broadened the authorized use of a daily pill to manage low libido in women to cover postmenopausal women up to age 65.

Before this week's decision, the drug, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was first approved by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

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

Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

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

“Previously, options were limited 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 group of women could be significant to address 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 reporters that the approval was “logical” given the available data.

While in favor, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

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.

The drug was initially researched as an medication for depression but was found to be lacking during early studies.

Nevertheless, researchers noted positive changes in aspects of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a significant advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of syncope. If a person consumes several drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund additional studies investigating the combination. The studies, which were limited in size, demonstrated no additional risk of syncope. But experts had reservations.

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

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

“There have been side effects like the fainting spells and dizziness 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 limited 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.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still broaden treatment options for HSDD to a new population of women who may benefit.

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

But it is not a magic bullet. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

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

Women after menopause navigate a wide variety of changes that can impact sexual desire. Symptoms of menopause include:

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

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

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

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

She hopes that the regulatory decision to lift of its “serious” 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 low libido in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about libido almost always start with relationships and intimacy.

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an expert. “This involves understanding 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 peak of sexual pleasure.”