Lemborexant: A New Class of Medication to Treat Sleep Disorders

Dr. Russell Rosenberg discusses the importance of asking patients about sleep disorders, treatment of sleep disorders and the latest data gathered from the SLEEP annual meeting (June 2018). Learn more from www.sleepfoundation.org

Dr. Russell Rosenberg is currently the Chief Science Officer of NeuroTrials Research, Inc. and Director of the Atlanta School of Sleep Medicine and Technology. He obtained his doctorate in clinical and research psychology from Ohio State University and received specialized training in sleep disorders medicine and research at Rush Presbyterian-St. Luke’s Medical center in Chicago. He has 30 years experience in clinical sleep medicine, research and teaching. He is a Board Certified Sleep Specialist, Fellow of the American Academy of Sleep Medicine and past Chairman of the Board of Directors, National Sleep Foundation (NSF).

Transcript

Neal Howard: Welcome to Health Professional Radio. I’m your host, Neal Howard. Our guest is Dr. Russell Rosenburg and we’re in conversation with him today as Principal Investigator in the Lemborexant studies and former Chairman of the Board of the National Sleep Foundation and we’re gonna talk today about the importance of asking patients about sleep disorders, some of the treatment for sleep disorders and some of the latest data that was gathered from the Sleep Annual Meeting held this month. Welcome to the program, Dr. Rosenburg.

Dr. Russell Rosenburg: Thank you very much. I appreciate your time today, Neal.

N: Have you always been involved in sleep disorders?

R: Yes. I have a 30-year career in sleep medicine and sleep research. Sleep problems are huge in our society. I think there’s a tremendous unmet need with regards to treating sleep problems and I think for decades people have made too little out of the consequences of not sleeping well and waking up well and performing well. So I’m pleased to be talking to you about these things today.

N: Well, I’ve heard fluctuating, for lack of a better term information throughout my life time about how much sleep a person is supposed to get, 6 hours, 6½, 7, 7½, 8, 8½? What is that perfect number for sleep or does it vary based on the individual and what that individual is involved in?

R: Well, indeed there are some variable needs with regards to sleep. Most people seem to need about 7 hours of sleep per night to feel well and rested and performing the next day. And the huge unmet need I was mentioning before is insomnia. That is patients who have trouble either falling asleep or staying asleep. And that’s what we were researching with regards to this new medication called Lemborexant which offers a new tool if you will for doctors who treat sleep disorders like insomnia.

N: So how does Lemborexant work?

R: Well, Lemborexant is a new class of medications that helps to sort of tamp down the parts of the brain that, that part do the wake-up signalling and it’s a bit complicated in the sense that a set of neurons that we have in our brain that keeps us awake could be working to the extent that it’s hard to fall asleep or it’s hard for sleep to occur. What Lemborexant does is essentially tamps down the wake-up signals that our brain is putting out and allows patients to sleep and this is
totally different from the way other sleeping pills put you to sleep as opposed to Lemborexant, allowing you to go to sleep. And what is important about some of the research that we presented recently in Baltimore at the Sleep Meeting, the Sleep 2018 Meeting is that with regards to the safety of a medication like Lemborexant, we presented data to show that patients could wake up in the middle of the night and still function in terms of comparing back to placebo, they did quite well. So waking up in the middle of the night is important. A lot of moms want to be able to wake up, a lot of patients want to be able to wake up and still perform whatever they need to perform in the middle of the night. We did one study in which we awake in patients purposely in the middle of the night to see about their ability to perform on various cognitive tests, as well as their ability to stand up and feel like they weren’t off-balance. We do what we call a sway test to see if patients feel steady on their feet.

N: This is a drug that a person can take. It allows them to go to sleep. They can be awakened in the middle of the night for whatever reason and then they’re able to resume sleep and still sleep out their cycle and feel refreshed in the morning with none of the side effects of say, those heavy sleeping aids like Ambien or some of the others that are out there.

R: Yes. Certainly, we want to be cautious about comparing because we really don’t have comparisons per se but we can clearly say is that we have evidence that just what you’ve mentioned is that is waking up, having people in this situation where they wake up after 4 hours of being in bed that they can perform as well as somebody who was taking a placebo pill – a sugar pill. And so what that shows us is that this medication is not going to cause adverse effects in the middle of the night and that’s an important time to be able to function. However, what’s just as important is to be able to get back to sleep quickly. It’s not how many times necessarily you wake up, it’s how long you’re awake in the middle of the night and once you’ve gone to sleep. So even with awakenings these subjects in the study that we presented at the Sleep Meeting they were able to fall asleep much faster than those that were on the placebo.

N: Is there any consideration taken to I guess the severity of a person’s insomnia? Because just having trouble going to sleep say maybe one or two nights out of a month, I don’t see that as a sleep disorder. In your opinion, what designates a true sleep disorder and could you address the question that our first post?

R: Sure. The kind of occasional Sunday night insomnia when patients are thinking about or an individual’s thinking about what’s going to happen the next week doesn’t meet the diagnostic criteria for insomnia disorder. There is a Diagnostic and Statistical Manual for psychiatric disorders and insomnia disorder requires that you have insomnia at least three nights a week over a period of three months. But Lemborexant is a medication that could be used either nightly or even intermittently and we don’t have the data to present and discuss with you today. We’re still looking at some of the data from trials in which we did take individuals who had chronic insomnia and we looked at their ability to fall asleep and stay asleep but that maybe for another time you ask me back to be on your show.

N: Well, when do you expect to be filing this NDA?

R: Well, I am not a representative of Eisai and the companies that are working together to put this drug forward and to have it available for physicians because of this unmet need. But I can tell you I believe that individuals who might be interested in trying this medication or physicians who are using to prescribe will still have a little while left until it gets completely approved.

N: Where can our listeners go online and learn some more about the National Sleep Foundation?

R: That’s a great question too. The Sleep Foundation is quite easy. It’s sleepfoundation. org and there’s a host of great information about insomnia and things you can do on your own to deal with this. I clearly know that that Eisai and Purdue, the two companies that are working together to bring Lemborexant forward will also have a lot on their websites about insomnia because they clearly have the intent of helping people who have this difficulty, who’ve been struggling with it and haven’t found a solution that works well for them that allows them to wake up and perform well.

N: Well, Dr. Rosenburg, I thank you so much for joining us today and sharing this great information with us. Hoping you’ll come back and speak with us again.

R: I’d be pleased to do that. Thanks so much for having me today.

N: You’ve been listening to Health Professional Radio. I’m your host, Neal Howard. Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm

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