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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Before the recent news, the medication, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA cited issues about safety, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s action to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs expressed support for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “logical” given the existing research.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

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

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

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

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund further research investigating the combination. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations.

“This research don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness 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 confusion about why the broader approval was limited 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, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

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

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

But it is not a quick fix. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors.

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

Women after menopause navigate a broad range of symptoms that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

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

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

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly 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 treatment option.

Testosterone is also sometimes prescribed off-label to address reduced desire in women, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

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

Other suggestions for increasing libido include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “That means knowing 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 peak of sexual pleasure.”