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Michael Thorpy, MD, professor of neurology, Albert Einstein College of Medicine explores the current treatment landscape of idiopathic hypersomnia and the associated challenges with approving new medication for this condition.
In an interview with The American Journal of Managed Care®, Michael Thorpy, MD, professor of neurology, Albert Einstein College of Medicine, previously discussed the role orexin antagonists in the treatment of idiopathic hypersomnia. Here, Thorpy continues by exploring the relevant challenges that arise when approving medications for idiopathic hypersomnia, as well as the current treatment landscape for this condition.
This topic and the latest news in sleep research were presented at the 2024 SLEEP: American Academy of Sleep Medicine and Sleep Research Society (APSS) Annual Meeting.
This transcript has been lightly edited for clarity.
Transcript
What are the main challenges in developing and approving new medications for idiopathic hypersomnia?
One of the problems with idiopathic hypersomnia is it’s not a solitary condition, it's a heterogeneous condition. And there are 2 main forms of it. There are some people who sleep a long time at night, and then are sleepy during the day, and there are other people who have a normal sleep episode at night and are sleepy during the day. So we have these 2 forms, and we don't understand the pathophysiology. That's the biggest challenge in trying to develop medications for the treatment of idiopathic hypersomnia, because we really don't understand what we need to target.
There's a little suggestion that orexin might be involved, hence the orexin agonists. There are some other studies that show that gamma-aminobutyric acid is involved. And so, that I think sorting out the pathophysiology will be the biggest challenge in developing new medications. And also clarifying the diagnosis because it's unclear—because we've got these 2 different types of idiopathic hypersomnia. Should there be different treatments targeting the different forms of idiopathic hypersomnia, for example. And so, diagnostic issues and understanding the pathophysiology are the biggest challenges going forward.
How do recent pharmacological advances in idiopathic hypersomnia compare with other treatment approaches, such as behavioral therapies or lifestyle changes?
When you're dealing with sleep problems, behavioral and lifestyle changes are always very important. It's very important for people with sleep disorders to maintain some regularity to their sleep-wake pattern, because we know that underlying our sleep-wake pattern [are] a very definitive circadian rhythm changes in many different aspects. For example, body temperature rises when we wake, cortisol level rises. Many neurotransmitters either rise or fall during sleep. So, many components of the body have a relationship with the sleep-wake cycle, and particularly the time of awakening.
So, if somebody has lifestyle factors that cause a very irregular and disrupted sleep pattern, that's going to make treatment a whole lot more difficult. So, maintaining a regular time of going to bed, regular time of getting up, and an appropriate amount of time in bed that suits the individual is very important. But despite that, these behavioral changes aren't going to correct idiopathic hypersomnia. They certainly are going to help with somebody who may be cutting themselves short of sleep and reduce some sleepiness related to insufficient sleep at night, but for idiopathic hypersomnia, patients are going to require medication in order to treat it, but it will be supplemented by these behavioral benefits of stabilizing the sleep-wake pattern; getting good, bright light; avoiding things like alcohol that disrupt sleep, etc. So, there are behavioral components that are very important.