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The Food and Drug Administration (FDA) widened the indication of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to 65 years old.

Prior to this week's decision, the pill, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was first approved by the FDA in two thousand fifteen, following a long and debated evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of Addyi applauded the FDA’s decision to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Other specialists in female health were supportive for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, 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 measured in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the enhancement is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

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

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

However, scientists noted positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major advocacy campaign.

Addyi 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 allowing a two-hour gap after consuming alcohol before using Addyi to minimize the chance of syncope. If a person consumes several drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the combination. The studies, which were limited in size, showed no additional risk of fainting. But medical professionals had reservations.

“This research aren't very convincing to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a health research president stated.

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

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at age 65.

“It's unclear if that has to do with the intricacies of the medication. Reviewing 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 prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still broaden treatment options for low desire to a new population of women who may benefit.

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

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a broad range of symptoms that can affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

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

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

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a viable choice.

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 sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending flibanserin after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “That means knowing 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 peak of sexual pleasure.”