🔗 Share this article

U.S. regulators expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to the age of sixty-five.

Prior to this week's decision, the drug, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

Flibanserin was originally authorized by the FDA in 2015, following a long and debated regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s move to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional specialists in female health expressed support for the decision.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be crucial to address women after menopause 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 “understandable” given the clinical evidence.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was originally developed as an medication for depression but was found to be lacking during early studies.

However, researchers observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

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

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

The label recommends waiting at least two hours after consuming alcohol before using Addyi to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually led the maker to fund further research investigating the interaction. The research, which were small in scale, showed no increased danger of fainting. 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 gynecologist suggested that this may have been part of the cause why the drug was not originally approved for older females.

“Patients have experienced side effects like the fainting spells and dizziness especially in individuals 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. Reviewing 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 Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for HSDD to a different group of women who may find help.

“I do think it will benefit 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 experts consulted all agreed that the female libido is influenced by many factors.

So treating HSDD means considering everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a wide variety of symptoms that can affect libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable prescribing 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 include:

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

“It requires an entire whole body approach to sexual health and menopause in older age,” said an expert. “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 excited, and ultimately to have a climax of sexual pleasure.”