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U.S. regulators expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in premenopausal females.

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

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional specialists in female health were supportive for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “understandable” given the available data.

Although supportive, 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 experiencing a dramatic change?”

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

Flibanserin, which is often called “female Viagra,” has little in common with the medication from which it gets its informal name.

This medication was originally developed as an medication for depression but was deemed ineffective during early studies.

Nevertheless, scientists noted positive changes in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a major advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance advises waiting at least two hours after drinking before using the drug to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the label advises 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 combination. The studies, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

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

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved 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 more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed uncertainty about why the broader approval was capped at age 65.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for low desire to a different group of females who may benefit.

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

But it is not a simple solution. In fact, the experts consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause experience a broad range of changes that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

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

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope 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 occasionally used without formal approval to treat reduced desire in women, although it is not indicated for it.

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

“I would have no problem prescribing Addyi 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 increasing sexual desire are:

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

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “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 climax of sexual pleasure.”