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The federal agency widened the indication of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to the age of sixty-five.

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.

This medication was first approved by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

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

“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 group of women could be very important to address 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 clinical evidence.

While in favor, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Addyi, which is often called “the women's version of Viagra,” has little in common 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.

Nevertheless, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after drinking before using the drug to minimize the chance of fainting. If a person has three or more alcoholic drinks on a given day, the label advises not taking the pill entirely.

Assertions about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were limited in size, showed no additional risk of syncope. But experts had concerns.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN speculated that this may have been part of the cause why Addyi 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 susceptible to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited at 65 years of age.

“I don’t know 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 approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

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

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

But it is not a simple solution. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.

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

Women after menopause navigate a wide variety of symptoms that can affect sexual desire. Symptoms of menopause encompass:

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

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

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both vaginal estrogen 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 “serious” warning on HRT 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 treat reduced desire in women, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be factored in. Conversations about libido 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 encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in later life,” said an expert. “That means understanding 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 orgasm.”