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U.S. regulators expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to 65 years old.

Prior to the recent news, the medication, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

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

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s action to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional women’s health experts expressed support for the decision.

“I had few tools for me to recommend because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be significant to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “logical” given the available data.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

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 first created as an antidepressant but was deemed ineffective during early studies.

Nevertheless, scientists noted improvements in measures of sexual function and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a considerable lobbying effort.

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

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

Claims about the effects of mixing the drug with drinking eventually led the maker to fund additional studies examining the combination. The research, which were small in scale, demonstrated no additional risk of syncope. But experts had reservations.

“This research don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

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

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

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

“I don’t know if that has to do with the intricacies of the drug. If you take 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 clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for HSDD to a different group of females who may find help.

“I believe it will serve this population better as long as they have no other medical problems,” said an specialist.

But it is not a simple solution. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward sexual wellness.

“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 hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less concerned about it and to consider it as a treatment option.

Androgen therapy is also sometimes used without formal approval to address low libido in females, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing Addyi 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.

Other recommendations for boosting sexual desire are:

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

“It requires an entire whole body approach to sexual health and menopause in later life,” said an expert. “That means 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 peak of sexual pleasure.”