🔗 Share this article

U.S. regulators widened the indication of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to the age of sixty-five.

Prior to the announcement, the medication, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

Flibanserin was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of Addyi praised the FDA’s move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs 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 approval for this group of women could be significant to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

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

While in favor, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was initially researched as an antidepressant but was deemed ineffective during initial trials.

However, researchers observed positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends waiting at least two hours after drinking before using the drug to reduce the risk of syncope. If a person has three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had reservations.

“These studies aren't very persuasive 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 reason why Addyi was not originally approved for postmenopausal women.

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

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

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, 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.

Treating Low Libido in Postmenopausal Women

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

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

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

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

Postmenopausal females experience a wide variety of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to alleviate the effects 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 apprehensive about it and to consider it as a treatment option.

Testosterone is also occasionally prescribed off-label to address reduced desire in women, although it is not officially approved for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an expert. “That means understanding how your body works, your anatomy, 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 sexual pleasure.”