Author Interviews, JAMA, Sleep Disorders / 28.12.2019
Insomnia: Lemborexant With Placebo vs Zolpidem Tartrate Extended Release
MedicalResearch.com Interview with:
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Dr. Moline[/caption]
Margaret Moline, PhD
Lemborexant International Program Lead and Global Medical Lead
Executive Director, Neurology Business Group
Eisai, Inc.
MedicalResearch.com: What is the background for this study?
This study, called SUNRISE 1, is one of two pivotal Phase 3 studies in the lemborexant clinical development program that supported the recent FDA approval of DAYVIGO (lemborexant).
Dr. Moline[/caption]
Margaret Moline, PhD
Lemborexant International Program Lead and Global Medical Lead
Executive Director, Neurology Business Group
Eisai, Inc.
MedicalResearch.com: What is the background for this study?
This study, called SUNRISE 1, is one of two pivotal Phase 3 studies in the lemborexant clinical development program that supported the recent FDA approval of DAYVIGO (lemborexant).
- On December 20, the U.S. Food and Drug Administration (FDA) approved DAYVIGO (lemborexant) 5 mg and 10 mg, an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, which is characterized by difficulties with sleep onset and/or sleep maintenance.1
- DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.
- SUNRISE 1 was a one-month, randomized, double-blind, placebo- and active-controlled, multi-center, parallel-group clinical trial in adult female patients age 55 and older and male patients 65 years and older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=208), lemborexant 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly.1
- The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS; defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness) from baseline to end of treatment (Days 29/30), as measured by overnight polysomnography (PSG) monitoring.1
- The pre-specified secondary efficacy endpoints in Study 2 were the mean change from baseline to end of treatment (Days 29/30) in sleep efficiency (SEF) and wake after sleep onset (WASO) measured by PSG.1
- SUNRISE 1, lemborexant 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo. lemborexant 5 mg and 10 mg demonstrated statistically significant improvement in SEF and WASO compared to placebo.1
- The effects of lemborexant at the beginning of treatment were generally consistent with later timepoints.



In a study of healthy volunteers, NIH researchers found that taking short breaks, early and often, may help our brains learn new skills.


Dr. Johnson[/caption]
Dayna A. Johnson PhD
Department of Epidemiology
Emory University
Atlanta, GA
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There are several studies that have determined that African Americans have the highest prevalence of hypertension and are the most likely to have uncontrolled hypertension compared to other racial/ethnic groups. We were interested in studying whether sleep apnea contributed to hypertension control among African Americans.
We found that participants with sleep apnea were more likely to have resistant hypertension than those without sleep apnea. In particular, individuals with severe sleep apnea had the highest risk of resistant hypertension. Most of the participants with measured sleep apnea were undiagnosed (96%).
Dr. Scullin[/caption]
Michael K. Scullin, Ph.D.
Assistant Professor of Psychology and Neuroscience
Director, Sleep Neuroscience and Cognition Laboratory
Baylor University
Waco, TX 76798
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There is a gap between what health behaviors individuals know they should adopt, and what those individuals actually end up doing. For example, a growing literature shows that simply educating students on the importance of sleep does not change their sleep behaviors. Thus, we need to think outside of the box for solutions.
In three classes, we have now investigated a motivational solution: if students can earn extra credit on their final exam for sleeping better, will they do so even during finals week?
