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The federal agency expanded its approval of a once-a-day medication to treat low libido in women to now encompass women after menopause up to age 65.

Before the recent news, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was originally authorized by the FDA in 2015, following a lengthy and contentious evaluation period.

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

Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of Addyi commended the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on female sexual health.

Other OB-GYNs were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “quite reasonable” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

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

Flibanserin, which is often called “female Viagra,” has few similarities with the drug from which it draws its nickname.

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

However, researchers observed improvements in measures of sexual function and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for serious side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label advises allowing a two-hour gap after consuming alcohol before using the drug to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the maker to fund further research examining the interaction. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

“These studies aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not initially cleared for older females.

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

Another doctor echoed uncertainty about why the expanded indication 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 easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a different group of females who may benefit.

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

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

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

Women after menopause experience a broad range of changes that can impact libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

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

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

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also sometimes used without formal approval to treat reduced desire in women, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about libido almost always start with relationships and intimacy.

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

Additional suggestions for boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and this life stage in older age,” said an expert. “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.”