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U.S. regulators broadened the authorized use of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to age 65.

Before the announcement, the medication, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial 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 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 approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of flibanserin commended the FDA’s action to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Other OB-GYNs were supportive for the regulatory move.

“I had few tools for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “understandable” given the existing research.

Although supportive, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is often called “female 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 considered unsuccessful during initial trials.

Nevertheless, scientists noted positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

The medication carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after consuming alcohol before taking the drug to minimize the chance of fainting. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the maker to fund additional studies examining the combination. The research, which were small in scale, showed no increased danger of fainting. But experts had reservations.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN suggested 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 treatment. When you get older, you become more sensitive to things like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped at 65 years of age.

“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.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a new population of women who may benefit.

“I believe it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a simple solution. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.

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

Postmenopausal females experience a broad range of changes that can affect libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

As noted by one expert, treating these symptoms is often a initial approach 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 systemic hormone therapy as treatments to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope 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 viable choice.

Androgen therapy is also sometimes prescribed off-label to address low libido in females, although it is not indicated for it.

But besides medication, experts say that personal habits should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an expert. “This involves knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”