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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to treat low libido in females to now encompass postmenopausal women up to 65 years old.

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

This medication was initially cleared by the FDA in 2015, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional OB-GYNs were supportive for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “logical” given the available data.

Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not substantial. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

This medication was originally developed as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a considerable lobbying effort.

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before using the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the maker to fund further research examining the interaction. The studies, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had concerns.

“These studies aren't very persuasive to me. They are a beginning, 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 cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the complexity of the drug. 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 simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for HSDD to a different group of females who may find help.

“I believe it will benefit this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a quick fix. In fact, the experts interviewed all agreed that the women's sexual desire is complex and multifaceted.

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

Women after menopause experience a broad range of symptoms that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the symptoms of menopause, particularly dryness.

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

Androgen therapy is also occasionally used without formal approval to address low libido in women, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I would have no problem recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing sexual desire are:

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

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “That means knowing how your body works, your physiology, 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.”