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U.S. regulators widened the indication of a daily pill 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 exclusively cleared to treat low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in 2015, following a protracted and controversial review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s action to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional specialists in female health voiced approval for the decision.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “logical” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it gets its informal name.

This medication was first created as an antidepressant but was found to be lacking during early studies.

Nevertheless, researchers observed improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label advises allowing a two-hour gap after drinking before taking the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research investigating the interaction. The studies, which were limited in size, showed no additional risk of fainting. But experts had concerns.

“These studies aren't very persuasive to me. They are a beginning, 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 cause why the drug was not originally approved for postmenopausal women.

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

Another doctor echoed confusion about why the broader approval was limited 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 dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a different group 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 specialist.

But it is not a magic bullet. In fact, the specialists consulted all agreed that the women's sexual desire is complex and multifaceted.

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

Postmenopausal females experience a broad range of symptoms that can impact libido. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward sexual wellness.

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

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly vaginal 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 prescribed off-label to address low libido in females, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

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

Other suggestions for increasing sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “This involves knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”