28 Dec Insomnia: Lemborexant With Placebo vs Zolpidem Tartrate Extended Release
MedicalResearch.com Interview with:
Margaret Moline, PhD
Lemborexant International Program Lead and Global Medical Lead
Executive Director, Neurology Business Group
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.
MedicalResearch.com: What should readers take away from your report?
Response: SUNRISE 1 was a pivotal study that compared lemborexant to placebo in patients with insomnia disorder. It included the first head-to-head comparison with pre-specified endpoints versus an active comparator. SUNRISE 1 achieved its primary objective by demonstrating that treatment with lemborexant resulted in a shorter time to sleep onset compared with placebo. It also achieved key secondary objectives.
Secondary endpoints, not adjusted for multiplicity, compared change from baseline in LPS, SE and WASO to active comparator at the end of the month of treatment, as well as change from baseline in WASO2H to placebo at the end of the month of treatment. These results were generally consistent with primary and key secondary endpoints. In addition, changes from baseline in LPS, SE, WASO and WASO2H were larger for both lemborexant doses than either placebo or active comparator.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: cannot disclose our plans for future evaluations of lemborexant
I can note that an investigational Phase 2 clinical study of lemborexant in patients with ISWRD and mild to moderate AD dementia is underway. Information about ongoing clinical studies is available at clinicaltrials.gov.
MedicalResearch.com: Is there anything else you would like to add?
Response: Notably, in SUNRISE 1, the reduction in time spent awake – approximately 45 minutes overall with lemborexant – was mostly in the second half of the night, a common time when people with sleep maintenance complaints experience difficulty staying asleep. Furthermore, lemborexant provided an improvement in sleep efficiency that translated into more than 60 minutes more sleep per night for patients than prior to treatment, which is a meaningful improvement for people with insomnia.
Rosenberg R, Murphy P, Zammit G, et al. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019;2(12):e1918254. doi:https://doi.org/10.1001/jamanetworkopen.2019.18254
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