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The federal agency broadened the authorized use of a once-a-day medication to manage low libido in women to now encompass women after menopause up to 65 years old.

Prior to this week's decision, the drug, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the agency cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the maker of flibanserin praised the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

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

“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be crucial 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 available data.

Although supportive, 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 overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?”

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

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

This medication was first created as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, scientists observed positive changes in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major lobbying effort.

The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before using Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research investigating the combination. The studies, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had reservations.

“This research 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 suggested that this may have been part of the cause why Addyi was not originally approved for older females.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped at age 65.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, 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 prescribing,” he said.

Treating Low Libido in Postmenopausal Women

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

“I do think it will benefit 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 specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a broad range of changes that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• 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 systemic hormone therapy as options to alleviate the symptoms of menopause, particularly dryness.

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

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

But besides medication, experts say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy.

“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.

Other suggestions for boosting libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “That means understanding 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 peak of orgasm.”