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The federal agency broadened the authorized use of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to 65 years old.

Prior to the recent news, the medication, Addyi (flibanserin), was solely authorized to address low sexual desire in women of reproductive age.

This medication 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 separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The founder and CEO of the maker of Addyi commended the FDA’s decision to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

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

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be very important to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “quite reasonable” 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 inactive pill, but the extent of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was initially researched as an antidepressant but was found to be lacking during early studies.

Nevertheless, scientists noted improvements in aspects of libido and arousal and shifted focus 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 considerable advocacy campaign.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance recommends waiting at least two hours after drinking before using the drug to minimize the chance of fainting. If a person has several drinks on a given day, the instructions recommends skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The studies, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had reservations.

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

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

“Patients have experienced side effects like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

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

“It's unclear if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, they are extensive. 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 After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a new population of females who may benefit.

“I believe it will serve this population better as long as they have no other health issues,” said an OB-GYN.

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

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

Postmenopausal females experience a wide variety of changes that can impact libido. Menopausal symptoms include:

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

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

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the effects of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to view it as a treatment option.

Testosterone is also occasionally used without formal approval to address reduced desire in females, although it is not indicated for it.

But besides medication, experts say that personal habits should also be factored in. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for boosting sexual desire are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or 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 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.”