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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to manage low libido in females to now encompass postmenopausal women up to the age of sixty-five.

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

The drug was first approved by the FDA in 2015, following a long and debated review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the agency cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s action to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health voiced approval for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be very important to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was found to be lacking during initial trials.

However, scientists observed positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for serious side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

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

Assertions about the effects of combining the drug with drinking eventually led the pharmaceutical company to fund further research examining the combination. The research, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“This research don’t seem 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 OB-GYN suggested that this may have been part of the reason why the drug was not originally approved 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 treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at 65 years of age.

“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, 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 clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still broaden treatment options for HSDD to a different group of women who may find help.

“I do think it will benefit this population better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the female libido is complex and multifaceted.

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

Women after menopause experience a broad range of symptoms that can affect libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

According to one expert, managing these issues is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Androgen therapy is also sometimes prescribed off-label to address low libido in females, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be considered. Discussions about sexual desire 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
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”