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U.S. regulators widened the indication of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Prior to the recent news, the drug, Addyi (flibanserin), was only approved to treat low sexual desire in women of reproductive age.

This medication was initially cleared 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 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

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

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “quite reasonable” 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 degree of the enhancement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

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

This medication was initially researched as an medication for depression but was deemed ineffective during initial trials.

However, researchers noted positive changes in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a serious safety warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label advises waiting at least two hours after consuming alcohol before using Addyi to reduce the chance of fainting. If a person consumes several drinks on a single occasion, the label advises skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually prompted the maker to fund additional studies examining the combination. The research, which were small in scale, showed no additional risk of syncope. But experts had concerns.

“This research aren't very convincing to me. They are a beginning, but they’re not very big 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 originally approved for postmenopausal women.

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

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

“It's unclear if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand treatment options for low desire to a different group of women who may benefit.

“I do think it will benefit this population 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 universally acknowledged that the female libido is influenced by many factors.

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

Postmenopausal females navigate a wide variety of changes that can affect sexual desire. Menopausal symptoms include:

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

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also sometimes prescribed off-label to address low libido in women, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing libido are:

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

“It requires an entire whole body approach to sexuality and menopause in older age,” said an expert. “This involves 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 peak of orgasm.”