Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
Summary
This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.
Timeline
- Start
- 2016-05-31
- Primary completion
- 2018-01-30
- Completion
- 2018-01-30
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Lemborexant 5 mg; p = 0.0003; Least Squares Geometric Mean(LSGM) Ratio 0.773 (95% CI 0.672 to 0.889) NCT02783729 ↗
registry analysis (superiority test); Placebo vs Lemborexant 10 mg; p < 0.0001; LSGM Ratio 0.723 (95% CI 0.628 to 0.832) NCT02783729 ↗
release “The Phase 3 pivotal study, SUNRISE 1, achieved its primary and key secondary objectives” eisai.com ↗
release “In SUNRISE 1, DAYVIGO 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo.” eisai.com ↗
release “SUNRISE 1 1 clinical trial conducted in North America and Europe utilized objective assessment with overnight measurement through polysomnography, and confirmed statistically significant shortening” eisai.com ↗
Publications
- Suzuki M, Yoshiike T, Khullar A, Kogo Y, Inabe K, Koebis M, Moline M, Cheng JY, Kumar D, Pinner K, Kuriyama K. Effects of lemborexant on sleep quality and its association with morning alertness: Post hoc analysis of two phase 3 trials. Sleep Med X. 2026 Mar 5;11:100183. doi: 10.1016/j.sleepx.2026.100183. eCollection 2026 Dec.
- Kushida CA, Zammit GK, Cheng JY, Kumar D, Moline M. Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apnea. Sleep Med. 2025 Mar;127:170-177. doi: 10.1016/j.sleep.2024.12.023. Epub 2024 Dec 17.
- Gotfried MH, Auerbach SH, Dang-Vu TT, Mishima K, Kumar D, Moline M, Malhotra M. Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. Drugs Aging. 2024 Sep;41(9):741-752. doi: 10.1007/s40266-024-01135-8. Epub 2024 Aug 9.
- Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.
- Inoue Y, Nishida M, Kubota N, Koebis M, Taninaga T, Muramoto K, Ishikawa K, Moline M. Comparison of the treatment effectiveness between lemborexant and zolpidem tartrate extended-release for insomnia disorder subtypes defined based on polysomnographic findings. J Clin Sleep Med. 2023 Mar 1;19(3):519-528. doi: 10.5664/jcsm.10378.
- Chepke C, Jain R, Rosenberg R, Moline M, Yardley J, Pinner K, Kumar D, Perdomo C, Filippov G, Atkins N, Malhotra M. Improvement in fatigue and sleep measures with the dual orexin receptor antagonist lemborexant in adults with insomnia disorder. Postgrad Med. 2022 Apr;134(3):316-325. doi: 10.1080/00325481.2022.2049553. Epub 2022 Mar 20.
- Citrome L, Juday T, Frech F, Atkins N Jr. Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2021 Jun 1;82:20m13795. doi: 10.4088/JCP.20m13795.
- Moline M, Zammit G, Cheng JY, Perdomo C, Kumar D, Mayleben D. Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder. J Clin Sleep Med. 2021 Jun 1;17(6):1167-1174. doi: 10.5664/jcsm.9150.
- Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. 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 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lemborexant | Small molecule | 5 mg | Oral |
| Subject | Lemborexant | Small molecule | 10 mg | Oral |
| Comparator | Zolpidem | Small molecule | 6.25 mg | Oral |