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The federal agency broadened the authorized use of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to the age of sixty-five.

Before this week's decision, the pill, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was initially cleared by the FDA in two thousand fifteen, following a long and debated review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

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

Additional OB-GYNs were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to address 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 decision was “logical” given the existing research.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the enhancement is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is often called “female Viagra,” has few similarities 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 positive changes in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following further studies and a major lobbying effort.

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.

The label recommends allowing a two-hour gap after drinking before using Addyi to reduce the chance of fainting. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had reservations.

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

An gynecologist suggested that this may have been part of the cause why Addyi was not initially cleared 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 older, you become more sensitive to effects like that,” she said.

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

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

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

“I believe it will benefit 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 low desire means considering everything from partnership issues to hormonal changes.

Postmenopausal females experience a wide variety of changes that can affect libido. Menopausal symptoms include:

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

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

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

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

Testosterone is also sometimes used without formal approval to treat reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting libido are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or 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 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.”