🔗 Share this article

The federal agency broadened the authorized use of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to the age of sixty-five.

Before this week's decision, the medication, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in women of reproductive age.

The drug was first approved by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s move to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Other women’s health experts were supportive for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, 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 first created as an medication for depression but was deemed ineffective during early studies.

However, scientists observed improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a therapy for low libido.

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

Addyi carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label recommends waiting at least two hours after drinking before using Addyi to minimize 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 interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the interaction. The studies, which were limited in size, showed no additional risk of fainting. But medical professionals had concerns.

“These studies don’t seem very convincing to me. They are a beginning, 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 reason why the drug was not originally approved for older females.

“There have been side effects like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed confusion about why the broader approval was limited at age 65.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

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

“I do think it will serve 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 interviewed all agreed that the female libido is complex and multifaceted.

So addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

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

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, managing these issues is often a initial approach toward improved intimacy.

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

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly dryness.

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

Testosterone is also occasionally used without formal approval to treat low libido in females, although it is not officially approved 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 psychosocial issues going on,” she said.

Other suggestions for increasing libido are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “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 excited, and ultimately to have a climax of orgasm.”