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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 now encompass postmenopausal women up to age 65.

Before the announcement, the medication, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was originally authorized by the FDA in 2015, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In both cases, the agency raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

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

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional specialists in female health expressed support for the regulatory move.

“I had few tools for me to recommend because available treatments 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 decision was “understandable” given the existing research.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was initially researched as an medication for depression but was deemed ineffective during early studies.

Nevertheless, scientists noted positive changes in aspects of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a significant lobbying effort.

The medication carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before using the drug to reduce the risk of syncope. If a person has several drinks on a given day, the label recommends skipping the dose entirely.

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

“These studies don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN speculated that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“There have been side effects like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

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

“I believe it will serve this population better as long as they have no other health issues,” said an specialist.

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

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

Women after menopause experience a broad range of symptoms that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, treating these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less concerned about it and to consider it as a viable choice.

Testosterone is also occasionally used without formal approval to treat low libido in females, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Discussions about libido almost always start with 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 recommendations for increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• using vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “This involves 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.”