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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to treat low libido in females to cover women after menopause up to 65 years old.

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

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

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 safety, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the maker of Addyi applauded the FDA’s action to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional women’s health experts expressed support for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be very important to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

This medication was first created as an antidepressant but was found to be lacking during initial trials.

Nevertheless, scientists noted positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for serious side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

The label advises allowing a two-hour gap after drinking before using the drug to minimize the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the maker to fund further research examining the interaction. The research, which were limited in size, demonstrated no additional risk of syncope. But experts had concerns.

“This research 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 OB-GYN speculated that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the broader approval was capped 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 dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

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

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

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

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a broad range of changes that can impact libido. Menopausal symptoms include:

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

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

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

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less concerned about it and to consider it as a viable choice.

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

But in addition to drugs, experts say that lifestyle should also be factored in. Discussions about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing 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 increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended foreplay
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an expert. “This involves 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 peak of sexual pleasure.”