U.S. Food and Drug Administration Clears Flibanserin, a Desire-Boosting Medication for Women After Menopause

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.

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

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The founder and CEO of the maker of flibanserin praised the FDA’s action to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional women’s health experts voiced approval for the regulatory move.

“I had few tools for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “logical” given the clinical evidence.

Although supportive, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the enhancement is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

This medication was initially researched as an antidepressant but was deemed ineffective during initial trials.

However, researchers observed improvements in measures of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

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

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label recommends waiting at least two hours after drinking before using Addyi to minimize the risk of syncope. If a person has several drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the maker to fund further research investigating the interaction. The studies, which were small in scale, showed no additional risk of fainting. But experts had concerns.

“This research don’t seem very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“There have been side effects like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire 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 universally acknowledged that the women's sexual desire is influenced by many factors.

So treating low desire means considering everything from partnership issues to hormonal changes.

Women after menopause experience a broad range of changes that can impact libido. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments 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 concerned about it and to consider it as a treatment option.

Androgen therapy 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 lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable prescribing flibanserin after having a conversation 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 are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “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 climax of sexual pleasure.”