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The Food and Drug Administration (FDA) expanded its approval of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to age 65.

Prior to the recent news, the pill, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was originally authorized by the FDA in two thousand fifteen, following a long and debated evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

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

The chief executive of the maker of flibanserin commended the FDA’s move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts were supportive for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be very important to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “logical” given the available data.

Although supportive, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

Addyi, which is often called “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was first created as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, scientists noted positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to reduce the risk of fainting. If a person has several drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research investigating the combination. The studies, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had concerns.

“This research don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for older females.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

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

“It's unclear if that has to do with the complexity 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 clinical decisions,” he said.

Treating Low Libido After Menopause

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a new population of females who may find help.

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

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

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

Women after menopause experience a wide variety of symptoms that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

According to 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? Are you comfortable?” she said.

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

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat 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. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“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.

Other recommendations for boosting sexual desire include:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in older age,” said an expert. “That means understanding 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 sexual pleasure.”