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The Food and Drug Administration (FDA) broadened the authorized use of a daily pill to address low libido in women to include women after menopause up to age 65.

Prior to the announcement, the pill, Addyi (flibanserin), was solely authorized to address low sexual desire in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a lengthy and contentious review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s move to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Additional OB-GYNs expressed support for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women 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 news outlets that the decision was “quite reasonable” given the available data.

While in favor, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?”

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

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was first created as an antidepressant but was considered unsuccessful during early studies.

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

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

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after consuming alcohol before using the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually led the maker to fund further research investigating the interaction. The research, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had reservations.

“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 health research president stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not initially cleared for older females.

“There have been side effects like the syncopal episodes and lightheadedness especially in individuals 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 expanded indication was capped at age 65.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. 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, Addyi could still broaden treatment options for HSDD to a different group of females who may benefit.

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

But it is not a simple solution. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors.

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

Postmenopausal females experience a broad range of symptoms that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, treating these symptoms 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? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate the symptoms 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 apprehensive about it and to consider it as a viable choice.

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be factored in. Conversations about sexual desire almost always start with partnership dynamics and closeness.

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

Additional recommendations for boosting sexual desire include:

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

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