Author Interviews, Eisai, Insomnia / 02.10.2020
SUNRISE 2 Trial: Long-Term Safety and Efficacy of DAYVIGO™ (lemborexant) For Insomnia in Adults
MedicalResearch.com Interview with: Margaret Moline, PhD Executive Director, Neurology Business Group, Eisai, Inc Lemborexant International Program Lead and Global Medical Lead MedicalResearch.com: What is the background for this study? What are the main findings?
- SUNRISE 2 was one of two pivotal Phase 3 studies evaluated in the U.S. Food and Drug Administration’s approval of DAYVIGO (lemborexant) CIV in December 2019.
- SUNRISE 2 was a pivotal six-month placebo-controlled treatment trial with a 6-month active treatment period including adult patients age 18 or older who met DSM-5 criteria for insomnia disorder.
- Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly for the first six months of the study (Treatment Period 1).
- The primary efficacy endpoint was the mean change from baseline to end of treatment at six months for subjective sleep onset latency (sSOL; the estimated minutes from the time that the patient attempted to sleep until sleep onset).
- Secondary efficacy endpoints were mean change from baseline to end of treatment at six months subjective sleep efficiency (sSE; the proportion of time spent asleep per time in bed) and subjective wake after sleep onset (sWASO; the minutes of wake from the onset of sleep until wake time). These endpoints were measured by sleep diary.
- At Virtual SLEEP 2020, a post-hoc analysis of SUNRISE 2 was shared in an oral presentation, which looked specifically at the long-term efficacy and safety of lemborexant in elderly adults with insomnia disorder.
- Insomnia disorder, a chronic condition with long-term consequences for health and well-being, is prevalent in older adults.
- This analysis of the SUNRISE 2 data reflects new learnings on the sustained impact of DAYVIGO on sleep onset and sleep maintenance in an older patient population.