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The Food and Drug Administration (FDA) expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to age 65.

Prior to the announcement, the drug, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was originally authorized by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional women’s health experts expressed support for the decision.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “understandable” given the existing research.

While in favor, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

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

This medication was originally developed as an antidepressant but was found to be lacking during initial trials.

Nevertheless, researchers noted improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

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

Official guidance recommends waiting at least two hours after consuming alcohol before using the drug to reduce the chance of syncope. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“This research aren't very convincing to me. They are a good start, 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 reason why Addyi was not originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink 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 confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. 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 simpler guidance because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

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

“I believe it will benefit 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 specialists interviewed universally acknowledged that the female libido is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause navigate a wide variety of changes that can affect libido. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a initial approach toward improved intimacy.

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

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly vaginal dryness.

She hopes 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 viable choice.

Androgen therapy is also sometimes prescribed off-label to treat reduced desire in females, although it is not indicated for it.

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

“I would have no problem recommending 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 recommendations for boosting sexual desire include:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “That means knowing how your body works, your physiology, 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 sexual pleasure.”