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U.S. regulators broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

Before the recent news, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency raised concerns about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared 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 expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

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

“Previously, options were limited 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 group of women could be significant to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “understandable” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was first created as an medication for depression but was found to be lacking during initial trials.

However, researchers noted positive changes in measures of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

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

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.

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to minimize the risk of fainting. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, showed no additional risk of fainting. But experts had reservations.

“These studies aren't very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“Patients have experienced side effects like the fainting spells and dizziness especially in individuals 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 echoed uncertainty 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. 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 simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a different group of females who may find help.

“I do think it will benefit this demographic better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the specialists consulted all agreed that the female libido is complex and multifaceted.

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

Postmenopausal females navigate a broad range of symptoms that can affect libido. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, treating these issues is often a first step toward sexual wellness.

“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 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 view it as a treatment option.

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

But besides medication, doctors say that lifestyle should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“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 sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• using sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “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 excited, and ultimately to have a climax of orgasm.”