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The Food and Drug Administration (FDA) broadened the authorized use of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to the age of sixty-five.

Before this week's decision, the pill, Addyi (flibanserin), was only approved to treat 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 agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of Addyi applauded the FDA’s move to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other specialists in female health voiced approval for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be significant to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the available data.

While in favor, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the improvement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was first created as an antidepressant but was deemed ineffective during initial trials.

However, scientists observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

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

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends allowing a two-hour gap after drinking before taking Addyi to minimize the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the effects of combining the drug with drinking eventually led the maker to fund further research investigating the combination. The research, which were small in scale, showed no additional risk of fainting. But medical professionals had concerns.

“These studies aren't very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“There have been side effects like the syncopal episodes and dizziness especially in individuals 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 confusion about why the expanded indication was limited 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 approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand therapeutic choices for low desire to a new population of females 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 complex and multifaceted.

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

Postmenopausal females navigate a wide variety of symptoms that can impact libido. Symptoms of menopause include:

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

According to 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: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a viable choice.

Testosterone is also sometimes 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 lifestyle should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing 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 recommendations for boosting sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “This involves knowing 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 climax of sexual pleasure.”