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The federal agency widened the indication of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to age 65.

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

This medication was initially cleared by the FDA in 2015, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the maker of flibanserin praised the FDA’s move to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other specialists in female health voiced approval for the regulatory move.

“There was nothing for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not overwhelming. Does it justify taking a drug daily and not seeing a major effect?”

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

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

This medication was initially researched as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, scientists observed improvements in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

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

Official guidance advises waiting at least two hours after consuming alcohol before using the drug to minimize the chance of fainting. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies examining the combination. The research, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns.

“These studies don’t seem very persuasive 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 the drug was not initially cleared for older females.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

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

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for low desire to a different group 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 experts consulted all agreed that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a wide variety of symptoms that can impact libido. Menopausal symptoms include:

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

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

“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as options to treat the symptoms 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 treatment option.

Androgen therapy is also sometimes used without formal approval to address low libido in women, although it is not indicated for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

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

Other recommendations for increasing sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”