Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)

Summary

The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective sleep maintenance in participants with insomnia disorder.

Timeline

Start

2016-11-15

Primary completion

2019-01-08

Completion

2019-01-08

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Lemborexant 5 mg; p <.0001; least squares geometric mean (LSGM)ratio 0.732 (95% CI 0.636 to 0.843); Mixed Models Analysis NCT02952820 ↗

registry analysis (superiority test); Placebo vs Lemborexant 10 mg; p <.0001; LSGM ratio 0.701 (95% CI 0.607 to 0.810); Mixed Models Analysis NCT02952820 ↗

release “In SUNRISE 2, DAYVIGO 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, sSOL, compared to placebo.” eisai.com ↗

release “SUNRISE 2 2 clinical trial, conducted globally including in Japan, evaluated patients subjectively through sleep diaries and confirmed statistically significant improvement in sleep onset latency” 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.
• Chepke C, Cote KA, Pinner K, Yardley J, Lundwall C, Moline M. Effect of Lemborexant on Daytime Functioning in Adults With Insomnia: Patient-Reported Outcomes From a Phase 3 Clinical Trial. Prim Care Companion CNS Disord. 2025 Jan 16;27(1):24m03810. doi: 10.4088/PCC.24m03810.
• Arnold V, Ancoli-Israel S, Dang-Vu TT, Mishima K, Pinner K, Malhotra M, Moline M. Efficacy of Lemborexant in Adults >/= 65 Years of Age with Insomnia Disorder. Neurol Ther. 2024 Aug;13(4):1081-1098. doi: 10.1007/s40120-024-00622-9. Epub 2024 May 15.
• 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.
• Terauchi M, Cheng JY, Yardley J, Pinner K, Moline M, Malhotra M, Inabe K, Nishida M, Pappadopulos E. Efficacy and safety of lemborexant in midlife women with insomnia disorder. Menopause. 2023 Aug 1;30(8):839-848. doi: 10.1097/GME.0000000000002209. Epub 2023 Jun 20.
• Dash A, Pinner K, Inoue Y, Hayashida K, Lim SC, Yun CH, Lan TH, Huang CL, Yardley J, Kubota N, Moline M. Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder. Sleep Med X. 2022 Mar 24;4:100044. doi: 10.1016/j.sleepx.2022.100044. eCollection 2022 Dec.
• 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.
• Roth T, Rosenberg R, Morin CM, Yardley J, Pinner K, Perdomo C, Atkins N Jr, Pappadopulos E, Malhotra M, Moline M. Impact of lemborexant treatment on insomnia severity: analyses from a 12-month study of adults with insomnia disorder. Sleep Med. 2022 Feb;90:249-257. doi: 10.1016/j.sleep.2022.01.024. Epub 2022 Feb 8.
• 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.
• Yardley J, Karppa M, Inoue Y, Pinner K, Perdomo C, Ishikawa K, Filippov G, Kubota N, Moline M. Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: results from a phase 3 randomized clinical trial. Sleep Med. 2021 Apr;80:333-342. doi: 10.1016/j.sleep.2021.01.048. Epub 2021 Feb 1.
• Inoue Y, Watanabe T, Takashima S, Takase T, Ishikawa K, Kubota N, Yardley J, Moline M. Efficacy and safety of lemborexant in adults with insomnia: comparing Japanese and non-Japanese subgroups from the global, phase 3, randomized, double-blind, placebo-controlled SUNRISE 2 study. J Clin Sleep Med. 2021 May 1;17(5):1067-1074. doi: 10.5664/jcsm.9148.
• Karppa M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. doi: 10.1093/sleep/zsaa123.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lemborexant	Small molecule	5 mg	Oral
Subject	Lemborexant	Small molecule	10 mg	Oral

Indications