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

NCT02952820 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: E2006-G000-3032015-001463-39
• Study Type: interventional
• Target: 971
• Locations: 12 countries
• Sites: 114

Brief 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.

Conditions

Insomnia Disorder

Keywords

insomnia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6

  sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.

  Baseline and Month 6

Secondary Outcomes (22)

• Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3

  Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3

• Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6

  Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6

• Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6

  Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6

• Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6

  Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6

• Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6

  Month 6

Study Arms (3)

lemborexant 5 milligrams (mg)

EXPERIMENTAL

Lemborexant 5 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Drug: lemborexant

lemborexant 10 mg

EXPERIMENTAL

Lemborexant 10 mg will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Drug: lemborexant

Placebo matched to lemborexant

PLACEBO COMPARATOR

Lemborexant-matched placebo will be taken orally in tablet form at home each night immediately before the time the participant intends to try to sleep.

Drug: Placebo

Interventions

lemborexant DRUG

lemborexant 10 mg; lemborexant 5 milligrams (mg)

Placebo DRUG

Placebo matched to lemborexant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 years or older at the time of informed consent
• Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria for Insomnia Disorder, as follows:
• Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep, difficulty staying asleep, and/or awakening earlier in the morning than desired despite adequate opportunity for sleep
• Frequency of complaint ≥3 times per week
• Duration of complaint ≥3 months
• Associated with complaint of daytime impairment
• History of (Subjective Sleep Onset Latency) sSOL ≥30 minutes on at least 3 nights per week in the previous 4 weeks and/or subjective Wake after Sleep Onset (sWASO) ≥60 minutes on at least 3 nights per week in the previous 4 weeks
• History of regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
• Regular bedtime, between 21:00 and 01:00 and regular wake time, the time the participant gets out of bed for the day, between 05:00 and 10:00
• Insomnia Severity Index (ISI) score ≥15
• Confirmation of current insomnia symptoms as determined from the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ≥30 minutes on at least 3 of the 7 nights and/or sWASO ≥60 minutes on at least 3 of the 7 nights
• Confirmation of time spent in bed, as determined from on the Sleep Diary completed on 7 mornings between the first and second screening visit, such that there are not more than 2 nights with duration of time spent in bed 7 hours and 10 hours
• Confirmation of regular bedtimes and wake times such that the participant has a regular time spent in bed, either sleeping or trying to sleep, between 7 and 10 hours for the final 7 nights of the before visit 3.
• Confirmation of regular bedtime between 21:00 and 01:00 and time of getting out of bed for the day between 05:00 and 10:00 for the final 7 nights of the before visit 3.
• Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night

You may not qualify if:

• STOPBang score greater than or equal to (\>=) 5
• International Restless Legs Scale (IRLS) score \>=16
• Epworth Sleepiness Scale (ESS) score \>15
• Reports symptoms potentially related to narcolepsy that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy
• Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior, eg, making phone calls, or preparing and eating food while asleep
• For participants who underwent polysomnography (PSG) within the previous year:
• Age 18 to 64 years: Apnea Hypopnea Index ≥10, or Periodic Limb Movements with Arousal Index ≥10
• Age ≥65 years: Apnea Hypopnea Index \>15, or Periodic Limb Movements with Arousal Index \>15
• Beck Depression Inventory - II (BDI II) score \>19 at Screening
• Beck Anxiety Inventory (BAI) score \>15 at Screening
• Habitually naps more than 3 times per week
• Females who are breastfeeding or pregnant at Screening or Study Baseline
• Females of childbearing potential who are not practicing acceptable pregnancy prevention methods (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.)
• Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study
• History of drug or alcohol dependency or abuse within approximately the previous 2 years

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (114)

Facility # 1

Chandler, Arizona, 85224, United States

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Chandler, Arizona, 85224, United States

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Rogers, Arkansas, 72758, United States

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Beverly Hills, California, 90210, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, 90069, United States

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Redlands, California, 92374, United States

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Sacramento, California, 95821, United States

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Santa Monica, California, 90404, United States

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Torrance, California, 90502, United States

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Colorado Springs, Colorado, 80909, United States

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Celebration, Florida, 34747, United States

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Hialeah, Florida, 33016, United States

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Homestead, Florida, 33030, United States

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Jacksonville, Florida, 32256, United States

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Lauderhill, Florida, 33319, United States

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Maitland, Florida, 32751, United States

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Innovative Clinical Research Inc

Miami, Florida, 33161, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32801, United States

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Oviedo, Florida, 32765, United States

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Pinellas Park, Florida, 33781, United States

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Tampa, Florida, 33634, United States

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The Villages, Florida, 32162, United States

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Evansville, Indiana, 47714, United States

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Elkridge, Maryland, 21075, United States

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Quincy, Massachusetts, 2169, United States

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Kansas City, Missouri, 64114, United States

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Albuquerque, New Mexico, 87109, United States

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Brooklyn, New York, 11235, United States

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Hickory, North Carolina, 28601, United States

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Dayton, Ohio, 45417, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97210, United States

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Lincoln, Rhode Island, 2865, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78731, United States

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Fort Worth, Texas, 76135, United States

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San Angelo, Texas, 76904, United States

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Seattle, Washington, 98101, United States

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Kelowna, British Columbia, Canada

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Toronto, Ontario, Canada

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Point-Claire, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Oulu, Oulun Laani, Finland

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Helsinki, Finland

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Kuopio, Finland

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Tampere, Finland

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Turku, Finland

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Turku, Finland

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Bochum, North Rhine-Westphalia, Germany

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Leipzig, Saxony, Germany

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Berlin, Germany

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Berlin, Germany

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Berlin, Germany

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Hamburg, Germany

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Hanover, Germany

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Milan, Lombardy, Italy

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Siena, Tuscany, Italy

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Roma, Italy

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Eisai Trail Site 1

Maebashi, Gunma, Japan

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Eisai Trail Site 1

Sapporo, Hokkaido, Japan

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Eisai Trail Site 2

Sapporo, Hokkaido, Japan

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Eisai Trail Site 3

Sapporo, Hokkaido, Japan

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Eisai Trail Site 4

Sapporo, Hokkaido, Japan

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Eisai Trail Site 1

Sagamihara, Kanagawa, Japan

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Eisai Trial Site 1

Yokohama, Kanagawa, Japan

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Eisai Trial Site 2

Yokohama, Kanagawa, Japan

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Eisai Trial Site 3

Yokohama, Kanagawa, Japan

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Eisai Trail Site 1

Tokorozawa, Saitama, Japan

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Eisai Trail Site 1

Arakawa City, Tokyo, Japan

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Eisai Trail Site 1

Katsushika-ku, Tokyo, Japan

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Eisai Trail Site 1

Minato, Tokyo, Japan

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Eisai Trail Site 2

Minato, Tokyo, Japan

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Eisai Trail Site 1

Musashino, Tokyo, Japan

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Eisai Trail Site 1

Ōta-ku, Tokyo, Japan

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Eisai Trail Site 2

Ōta-ku, Tokyo, Japan

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Eisai Trail Site 3

Ōta-ku, Tokyo, Japan

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Eisai Trail Site 1

Shibuya City, Tokyo, Japan

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Eisai Trail Site 1

Shinagawa, Tokyo, Japan

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Eisai Trail Site 2

Shinagawa, Tokyo, Japan

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Eisai Trail Site 1

Shinjuku, Tokyo, Japan

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Eisai Trail Site 2

Shinjuku, Tokyo, Japan

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Eisai Trail Site 1

Toshima City, Tokyo, Japan

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Facility # 1

Monterrey, Nuevo León, Mexico

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Wellington, North Island, New Zealand

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Christchurch, South Island, New Zealand

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Dunedin, South Island, New Zealand

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Auckland, New Zealand

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Rotorua, New Zealand

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Tarnów, Lesser Poland Voivodeship, Poland

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Warsaw, Masovian Voivodeship, Poland

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Gdansk, Poland

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Katowice, Poland

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Ostróda, Poland

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Warsaw, Poland

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Warsaw, Poland

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Brasov, Romania

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Bucharest, Romania

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Constanța, Romania

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Sibiu, Romania

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Târgu Mureş, Romania

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Seongnam-si, Gyeonggido, South Korea

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Suwon, Gyeonggido, South Korea

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Daegu, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Palma de Mallorca, Balearic Islands, Spain

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Torrejón de Ardoz, Madrid, Spain

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Quart de Poblet, Valencia, Spain

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Barcelona, Spain

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Valencia, Spain

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Related Publications (11)

• 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.

  PMID: 39823487 DERIVED

• 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.

  PMID: 38748321 DERIVED

• 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.

  PMID: 37796657 DERIVED

• 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.

  PMID: 37339396 DERIVED

• 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.

  PMID: 35402894 DERIVED

• 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.

  PMID: 35254948 DERIVED

• 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.

  PMID: 35220140 DERIVED

• 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.

  PMID: 34077032 DERIVED

• 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.

  PMID: 33636648 DERIVED

• 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.

  PMID: 33576735 DERIVED

• 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.

  PMID: 32585700 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai, Inc.

esi_medinfo@eisai.com

+1-888-274-2378

Study Officials

• Eisai Medical Information

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: November 15, 2016
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: February 6, 2020
• Results First Posted: January 21, 2020

Record last verified: 2017-12

Locations

JP (24); FI (6); US (42); ME (1); KR (5); CA (4); RO (5); DE (7); IT (3); ES (5); PL (7); NZ (5)