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The Food and Drug Administration (FDA) widened the indication of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

Before this week's decision, the pill, Addyi (flibanserin), was solely authorized 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 lengthy and contentious regulatory scrutiny.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the maker of flibanserin commended the FDA’s action to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other specialists in female health expressed support for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “understandable” given the existing research.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the improvement is not substantial. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Addyi, which is often called “female Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was first created as an antidepressant but was deemed ineffective during initial trials.

However, scientists noted positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort.

The medication carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had concerns.

“These studies don’t seem 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 speculated that this may have been part of the reason why the drug was not originally approved for older females.

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

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

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions 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 females who may benefit.

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

But it is not a quick fix. In fact, the specialists consulted all agreed that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

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

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

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

“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 vaginal estrogen and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also sometimes used without formal approval to address low libido in women, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting sexual desire include:

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

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”