🔗 Share this article

The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to 65 years old.

Before the recent news, the medication, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s move to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Additional women’s health experts voiced approval for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was first created as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists observed improvements in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises waiting at least two hours after drinking before using Addyi to reduce the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions advises skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of syncope. But experts had concerns.

“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 health research president stated.

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

“There have been adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor echoed uncertainty 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. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a different group of females who may find help.

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

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the female libido is influenced by many factors.

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

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

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

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

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

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

She hopes that the regulatory decision to lift of its “serious” 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 prescribed off-label to treat low libido in females, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always start with partnership dynamics and closeness.

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

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

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an expert. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”