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U.S. regulators broadened the authorized use of a once-a-day medication to treat low libido in women to now encompass women after menopause up to 65 years old.

Prior to the announcement, the drug, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.

This medication was first approved by the FDA in 2015, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the agency raised concerns about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s move to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Other women’s health experts were supportive for the decision.

“There was nothing 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 crucial to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “quite reasonable” given the existing research.

Although supportive, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the improvement is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it draws its nickname.

The drug was first created as an medication for depression but was deemed ineffective during early studies.

However, scientists observed improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually prompted the maker to fund further research examining the combination. The studies, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had concerns.

“These studies don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An gynecologist speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed 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 instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a different group of women who may benefit.

“I do think it will serve 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 universally acknowledged that the women's sexual desire is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

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

Testosterone is also sometimes prescribed off-label to address reduced desire in women, although it is not indicated for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about sexual desire almost always begin by focusing on 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 sexual desire are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an expert. “That means understanding 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 peak of orgasm.”