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The federal agency broadened the authorized use of a once-a-day medication to manage low libido in women to cover postmenopausal women up to the age of sixty-five.

Before the announcement, the drug, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was initially cleared by the FDA in 2015, following a lengthy and contentious evaluation period.

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

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s move to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Other women’s health experts were supportive for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “quite reasonable” given the existing research.

While in favor, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

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

Addyi, which is often called “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

However, researchers noted improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a serious safety warning for serious side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

The label recommends waiting at least two hours after drinking before taking Addyi to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

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

“These studies aren't very persuasive 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 gynecologist suggested 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 fainting spells and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at age 65.

“I don’t know 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 cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

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

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

But it is not a quick fix. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a broad range of changes that can affect libido. Menopausal symptoms encompass:

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

As noted by one expert, treating these issues is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

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

Testosterone is also sometimes used without formal approval to treat low libido in women, although it is not officially approved 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 partnership dynamics and closeness.

“I am comfortable recommending flibanserin 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.

Additional suggestions for boosting libido include:

• 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 entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “This involves knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”