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

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

This medication was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the maker of flibanserin praised the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional specialists in female health voiced approval for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be very important to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “understandable” given the available data.

Although supportive, the expert was cautious 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 every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

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

However, scientists noted positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following further studies and a significant advocacy campaign.

The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before taking 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.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were limited in size, showed no additional risk of fainting. But experts had concerns.

“These studies aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An gynecologist speculated that this may have been part of the reason why Addyi was not initially cleared for older females.

“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 sensitive to things like that,” she said.

Another doctor expressed confusion about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still broaden therapeutic choices for low desire to a new population of females who may benefit.

“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 all agreed that the female libido is complex and multifaceted.

So addressing HSDD means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a broad range of symptoms that can affect sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

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

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat reduced desire in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Conversations about libido 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 psychosocial issues going on,” she said.

Additional suggestions for boosting sexual desire include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “That means knowing 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 orgasm.”