Nancy Foldvary, DO, MS

“We know based on the primary paper, which was published recently, that lower sodium oxybate is efficacious for excessive daytime sleepiness, measured by the Epworth Sleepiness Scale, and cataplexy. And now we know from these newer data in narcolepsy that it is more beneficial than placebo therapy in health-related quality of life outcomes.”

Lower sodium oxybate (LXB) has efficacy in line with sodium oxybate (SXB; Xyrem; Jazz Pharmaceuticals) for the treatment of cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy, according to data from a recent study presented at the 

2021 American Academy of Neurology (AAN) Annual Meeting

, April 17-22, by Nancy Foldvary-Schaefer, DO, MS, director, Sleep Disorders Center, Cleveland Clinic.

Foldvary-Schaefer and colleagues found that 91% of those taking SXB at study entry had no dose adjustment or adjustments within 1 titration step (±1.5 g/night). The median number of adjustments was 0.0 (range, 0-8) in participants taking SXB at study entry and 3.0 (range, 0-7) in participants not taking SXB at study entry.

 spoke with Foldvary-Schaefer to learn more about the various studies on LXB presented at AAN 2021, including their findings and their motivations for conducting such studies. She additionally discussed the medication’s potential in treating idiopathic hypersomnia, another common sleep-related disorder for which sodium oxybate is not yet indicated.

1. Foldvary-Schaefer NR, Bogan RK, Thorpy MJ, Huang L, Skowronski R, Dauvilliers Y. Lower-sodium oxybate dose titration and transition from sodium oxybate in a placebo-controlled, double-blind, randomized withdrawal study in adult participants with narcolepsy with cataplexy. Presented at 2021 American Academy of Neurology Annual Meeting; April 17-22. Abstract P26 013

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The director of the sleep disorders center at Cleveland Clinic discussed the data on lower sodium oxybate presented at AAN 2021. 

Lower Sodium Oxybate for Excessive Sleepiness, Narcolepsy, and Hypersomnia: Nancy Foldvary-Schaefer, DO, MS

“The main advantage of lower sodium oxybate over sodium oxybate is the sodium content. Lower sodium oxybate contains 92% less sodium. The full dose of sodium oxybate, or Xyrem, contains over 1600 milligrams of sodium a day, which is more than the recommended daily allowance of sodium.”

Data from a recent study presented at the 

, April 17-22, by Nancy Foldvary-Schaefer, DO, MS, director, Sleep Disorders Center, Cleveland Clinic suggest that lower-sodium oxybate (LXB) has efficacy in line with sodium oxybate (SXB; Xyrem; Jazz Pharmaceuticals) for the treatment of cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy.

 spoke with Foldvary-Schaefer to learn more about the advantages of LXB over SXB. She also discussed further research being conducted in the treatment and more research she would like to see conducted.

The director of the sleep disorders center at Cleveland Clinic discussed her investigations into low-sodium oxybate presented at AAN 2021. 

Lower Sodium Oxybate for Narcolepsy: Nancy Foldvary-Schaefer, DO, MS

Although many people experience periodic or chronic insomnia, the sleep disorder is severely underdiagnosed and undertreated. The toll that poor sleep can have on overall health is immense, which should make addressing this sleep disorder top of mind among healthcare professionals.  

Currently available pharmaceutical treatments are associated with troubling side effects, including next-day drowsiness that can impact a patient’s ability to function normally. Investigational orexin receptor antagonists, including lemborexant, may hold significant treatment benefits for patients with insomnia without the residual next-day effects. Additionally, cognitive behavioral therapy is recommended as first-line therapy for insomnia, although it can sometimes be challenging to motivate patients to implement those strategies.  

, Nancy Foldvary, DO, MS, director of the Cleveland Clinic Sleep Disorder Center, and a staff member at the Cleveland Clinic Epilepsy Center, emphasized the importance of prioritizing sleep problems and seeking help to correct them. She detailed some of the challenges of diagnosing insomnia and the different therapeutic options that are currently available, and those that might soon be available.

: What are the challenges in diagnosing insomnia?

: Insomnia is a challenge because insomnia can be a symptom of so many health problems, but it can also be in and of itself a disorder. At least 15% of adult Americans suffer with a chronic insomnia disorder. This leads to chronic sleep insufficiency and  sleep loss. Like other disorders, for example, sleep apnea, where we recognize that sleep apnea is associated with cardiovascular disease and metabolic disorders and even changes in brain health, the same would be true with a chronic insomnia disorder. But because it's more of a clinical diagnosis, not a diagnosis that you make at a sleep laboratory, and because it can be a symptom of so many other things, there can be confusion and perhaps a lack of recognition and underdiagnosis. At the end of the day, doctors in medical school only get 1 to 2 hours of sleep training all 4 years of medical school, yet sleep is fundamental to health. It's like diet and exercise. It affects every cell in the body. So therefore, lack of sleep might affect every organ system. And yet, there's just under-recognition. Particularly as primary care doctors get busier and busier, managing all the different health problems of a patient, some of these fundamental issues like sleep can easily get ignored.

Do you feel as though lemborexant and other drugs will address the treatment gap that current treatments leave with residual negative next-day effects? 

It's great to have drugs that have different mechanisms of action than what we've used previously. Studies and big meta analyses clearly have shown that to treat a chronic insomnia disorder, cognitive behavioral therapy for insomnia actually works as well, if not better than a sleep drug, and for longer periods of time. What happens early on in the course of the brain, and the behaviors of somebody developing a chronic insomnia disorder, is that, as humans we develop habits that perpetuate cognitive thoughts that are misperceptions. And so that's actually how a chronic insomnia develops. The best therapy is to invest the effort, which can be difficult to convince patients to do so, to really work through the behavioral responses that are wrong or incorrect, and then the cognitive distortions about sleep, the concept that “I have to have 8 hours of sleep or I'm not going to function tomorrow,” some of these sorts of cognitive distortions that helped perpetuate the process. Doing that is so much more powerful than trying the next sleep drug. Once you've tried 1 and 2 and 3, as sleep doctors, generally the fourth and fifth, even if they're novel, are likely not to be all that effective, and that's because you're giving them to people who have chronic behavioral strategies that work against ensuring a good night sleep.

A couple of years ago at the Cleveland Clinic, our sleep team, led by Michelle Drerup, PsyD, the behavioral sleep medicine director, worked with the Wellness Institute and developed a computerized web-based program to do cognitive behavioral therapy for insomnia. It's simple for people who like to do self-help on the computer. It addresses the core concepts within the whole cognitive behavioral therapy treatment, from sleep hygiene, just making sure your bedroom is the right temperature and the pillow is right, and you're not drinking caffeine before bed, to the more complicated, cognitive restructuring. That's a therapy that anyone can access online for small amount of money that can be used for a lifetime. I think as sleep providers, we really need to do a better job at educating  other kinds of providers, including neurologists, cardiologists, and primary care doctors about the relative benefits of doing that kind of therapy, which is very cost effective, relative to the risks and costs associated with new sleep aids.

What are the differences in adherence when comparing cognitive behavioral therapy versus a pill therapy?

We have to tailor all therapies to the individual. For very mild insomnia that is chronic, we would not want to begin that cycle of sleep aids. Because you start one, it may work for a while, stop working, you escalate to the next, and it just goes on and on. We would prefer to be able to introduce cognitive behavioral therapy as a core. This is the treatment for mild, maybe moderate insomnia, before any process of prescribing medications begins. This is what we do in the sleep center. We don't write sleep aids, generally, for mild to moderate insomnia without first going through that cognitive behavioral therapy. There are patients who are very resistant to that and we negotiate. I might use a sleep aid for 6 to 8 weeks while they're doing this program with the specific intent that once they successfully implement some of those strategies we’ll begin to take it away, take the medication away or taper the medication or maybe allow patients to use the medication only for specific situations. In patients who are coming for the next drug, and they failed every other one before it, and they're not willing to do the basic, fundamental work of ensuring that they have the appropriate behavioral and cognitive interactions with sleep, those patients will continue to have bad insomnia and continue to be dissatisfied. Typically these medications don't work by restoring, what is viewed as normal sleep, for all infinity.

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Nancy Foldvary, DO, MS, director of the Cleveland Clinic Sleep Disorder Center, discussed challenges faced when treating insomnia.

Nancy Foldvary, DO, MS

Articles

Lower Sodium Oxybate for Excessive Sleepiness, Narcolepsy, and Hypersomnia: Nancy Foldvary-Schaefer, DO, MS

Lower Sodium Oxybate for Narcolepsy: Nancy Foldvary-Schaefer, DO, MS

Addressing Insomnia With Cognitive Behavioral Therapy

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