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The federal agency widened the indication of a oral treatment to manage low libido in women to cover postmenopausal women up to age 65.

Prior to the announcement, the pill, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was originally authorized 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 again in 2013. In both cases, the FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s move to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other specialists in female health expressed support for the regulatory move.

“There was nothing for me to recommend because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the enhancement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

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

Addyi, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

This medication was originally developed as an medication for depression but was found to be lacking during early studies.

However, researchers observed improvements in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for serious 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 consuming alcohol before taking Addyi to reduce the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the maker to fund additional studies investigating the interaction. The research, which were limited in size, showed no additional risk of fainting. But experts had concerns.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An OB-GYN speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“There have been side effects like the fainting spells and lightheadedness especially in persons 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 expressed uncertainty about why the expanded indication was capped at 65 years of age.

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand treatment options for HSDD to a new population 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 OB-GYN.

But it is not a quick fix. In fact, the experts interviewed all agreed that the female libido is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

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

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

According to one expert, managing these symptoms is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my initial inquiry 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 alleviate the symptoms of menopause, particularly dryness.

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

Androgen therapy is also occasionally used without formal approval to treat low libido in females, although it is not indicated for it.

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

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing libido include:

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

“It requires an entire whole body approach to sexual health and menopause in older age,” said an expert. “That means 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 orgasm.”