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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to the age of sixty-five.

Before this week's decision, the drug, Addyi (flibanserin), was exclusively cleared to address low sexual desire in women of reproductive age.

Flibanserin was first approved by the FDA in 2015, 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 raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s move to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

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

“Previously, options were limited 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 group of women could be very important to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “logical” given the existing research.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?”

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

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the medication from which it gets its informal name.

The drug was initially researched as an medication for depression but was found to be lacking during early studies.

However, researchers observed improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises waiting at least two hours after consuming alcohol before using Addyi to minimize the chance of syncope. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had reservations.

“This research aren't very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

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

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

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the instructions and restrictions, 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.

Addressing Low Libido After Menopause

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

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

But it is not a quick fix. In fact, the specialists interviewed universally acknowledged that the female libido is influenced by many factors.

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

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

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

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

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

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to treat reduced desire in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for boosting sexual desire are:

• getting more sleep
• exercising
• staying active
• using 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 sexual health and this life stage in older age,” said an expert. “This involves understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”