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U.S. regulators broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to the age of sixty-five.

Before the recent news, the medication, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the agency expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Other women’s health experts were supportive for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be significant to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?”

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

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

The drug was originally developed as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, researchers noted positive changes in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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 severe side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label recommends waiting at least two hours after consuming alcohol before using the drug to minimize the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Claims 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 medical professionals had concerns.

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

An gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for older females.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was capped at 65 years of age.

“It's unclear 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 cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

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

But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

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

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, treating these issues is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? 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 FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also sometimes prescribed off-label to address reduced desire in women, although it is not officially approved for it.

But in addition to drugs, experts say that lifestyle should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem recommending 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.

Additional suggestions for increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and menopause in later life,” said an expert. “This involves understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”