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U.S. regulators expanded its approval of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Before this week's decision, the drug, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication 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 each instance, the FDA expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

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

Additional OB-GYNs voiced approval for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women 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 decision was “logical” given the existing research.

While in favor, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

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

The drug was initially researched as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, scientists observed improvements in measures of sexual function 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 hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

Addyi carries a serious safety warning for serious adverse reactions, 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 taking the drug to minimize the risk of fainting. If a person has several drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies examining the interaction. The research, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“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 Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells 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 sensitive to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand therapeutic choices for low desire to a new population of women who may benefit.

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

But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is influenced by many factors.

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females navigate a broad range of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a initial approach 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 suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to view it as a viable choice.

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

But besides medication, experts say that lifestyle should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for increasing libido are:

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

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “This involves knowing how your body works, your anatomy, 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 sexual pleasure.”