Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder
Study objectives: Lemborexant (LEM) is a dual orexin receptor antagonist approved for treating adults with insomnia. We analyzed the efficacy (subjective sleep outcomes) and safety of LEM over 12 months in the subgroup of Asian subjects from Study E2006-G000-303 (Study 303). Methods: Study 303 was a...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Sleep Medicine: X |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590142722000039 |
| _version_ | 1819010116996825088 |
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| author | Amitabh Dash Kate Pinner Yuichi Inoue Kenichi Hayashida Sung Chul Lim Chang-Ho Yun Tsuo-Hung Lan Chieh-Liang Huang Jane Yardley Naoki Kubota Margaret Moline |
| author_facet | Amitabh Dash Kate Pinner Yuichi Inoue Kenichi Hayashida Sung Chul Lim Chang-Ho Yun Tsuo-Hung Lan Chieh-Liang Huang Jane Yardley Naoki Kubota Margaret Moline |
| author_sort | Amitabh Dash |
| collection | DOAJ |
| description | Study objectives: Lemborexant (LEM) is a dual orexin receptor antagonist approved for treating adults with insomnia. We analyzed the efficacy (subjective sleep outcomes) and safety of LEM over 12 months in the subgroup of Asian subjects from Study E2006-G000-303 (Study 303). Methods: Study 303 was a 12-month, randomized, placebo-controlled (first 6 months), double-blind, parallel-group, phase 3 study of adults with insomnia disorder. During the 6-month Period 1, subjects were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10); LEM subjects continued treatment in the following 6-month Period 2. Outcome measures included subject-reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Insomnia Severity Index (ISI), and Patient Global Impression–Insomnia version (PGI-I). Treatment-emergent adverse events (TEAEs) were assessed. Results: Overall, 178 Asian subjects (Japanese, n = 161; Chinese, n = 4; other Asian, n = 13) were included. Greater decreases in sSOL and sWASO and increases in sSE and sTST from baseline were observed with LEM vs placebo at 6 months; LEM benefits were sustained through 12 months. Greater decreases in ISI total score were seen with LEM vs placebo at 6 months; improvements from baseline with LEM continued through 12 months. For each PGI-I item, LEM-treated subjects had more positive medication effects than placebo-treated subjects at 6 months; these effects were maintained with LEM in Period 2. TEAEs were generally mild to moderate. Conclusions: LEM improved subjective sleep parameters and was well-tolerated in Asian subjects with insomnia disorder over 12 months. Clinical trial registration: ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39. |
| first_indexed | 2024-12-21T01:07:09Z |
| format | Article |
| id | doaj.art-a8c72a7e621a4ab98e20c02d82cd3b54 |
| institution | Directory Open Access Journal |
| issn | 2590-1427 |
| language | English |
| last_indexed | 2024-12-21T01:07:09Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Sleep Medicine: X |
| spelling | doaj.art-a8c72a7e621a4ab98e20c02d82cd3b542022-12-21T19:21:02ZengElsevierSleep Medicine: X2590-14272022-12-014100044Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorderAmitabh Dash0Kate Pinner1Yuichi Inoue2Kenichi Hayashida3Sung Chul Lim4Chang-Ho Yun5Tsuo-Hung Lan6Chieh-Liang Huang7Jane Yardley8Naoki Kubota9Margaret Moline10Eisai Singapore Pte Ltd, 152 Beach Road, #15-05/08 Gateway East, 189721, SingaporeEisai Ltd., Mosquito Way, Hatfield AL10 9SN, UKTokyo Medical University, 6 Chome-1-1 Shinjuku, Shinjuku City, Tokyo 160-8402, JapanSleep Support Clinic, 1 Chome-18-8 Higashiōi, Shinagawa City, Tokyo 140-0011, JapanThe Catholic University of Korea, St. Vincent's Hospital, 93 Jungbu-daero, Ji-dong, Paldal-gu, Suwon, Gyeonggi-do, Republic of KoreaDepartment of Neurology, Bundang Clinical Neuroscience Institute, Seoul National University Bundang Hospital, 173 Gumi-ro, beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of KoreaTsaotun Psychiatric Center, Ministry of Health and Welfare, 161 Yu-Pin Road, Tsaotun, Nantou 54249, Taiwan; Department of Medicine, National Yang Ming Chiao Tung University, 155, Sec. 2 Li-Nong Street, Beitou, Taipei 11221, Taiwan; Center for Neuropsychiatric Research, National Health Research Institutes, 35 Keyan Road, Zhunan Town, Miaoli 35053, Taiwan; Institute of Clinical Medicine, National Yang Ming Chiao Tung University, 155, Sec. 2 Li-Nong Street, Beitou, Taipei 11221, TaiwanTsaotun Psychiatric Center, Ministry of Health and Welfare, 161 Yu-Pin Road, Tsaotun, Nantou 54249, TaiwanEisai Ltd., Mosquito Way, Hatfield AL10 9SN, UKEisai Co., Ltd, 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, JapanEisai Inc., 200 Metro Blvd, Nutley, NJ 07110, USA; Corresponding author. Clinical Research, Eisai Inc., 200 Metro Blvd, Nutley, NJ 07110, USA.Study objectives: Lemborexant (LEM) is a dual orexin receptor antagonist approved for treating adults with insomnia. We analyzed the efficacy (subjective sleep outcomes) and safety of LEM over 12 months in the subgroup of Asian subjects from Study E2006-G000-303 (Study 303). Methods: Study 303 was a 12-month, randomized, placebo-controlled (first 6 months), double-blind, parallel-group, phase 3 study of adults with insomnia disorder. During the 6-month Period 1, subjects were randomized (1:1:1) to placebo, LEM 5 mg (LEM5), or LEM 10 mg (LEM10); LEM subjects continued treatment in the following 6-month Period 2. Outcome measures included subject-reported (subjective) sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO), total sleep time (sTST), Insomnia Severity Index (ISI), and Patient Global Impression–Insomnia version (PGI-I). Treatment-emergent adverse events (TEAEs) were assessed. Results: Overall, 178 Asian subjects (Japanese, n = 161; Chinese, n = 4; other Asian, n = 13) were included. Greater decreases in sSOL and sWASO and increases in sSE and sTST from baseline were observed with LEM vs placebo at 6 months; LEM benefits were sustained through 12 months. Greater decreases in ISI total score were seen with LEM vs placebo at 6 months; improvements from baseline with LEM continued through 12 months. For each PGI-I item, LEM-treated subjects had more positive medication effects than placebo-treated subjects at 6 months; these effects were maintained with LEM in Period 2. TEAEs were generally mild to moderate. Conclusions: LEM improved subjective sleep parameters and was well-tolerated in Asian subjects with insomnia disorder over 12 months. Clinical trial registration: ClinicalTrials.gov, NCT02952820; ClinicalTrialsRegister.eu, EudraCT Number 2015-001463-39.http://www.sciencedirect.com/science/article/pii/S2590142722000039Asian continental ancestry groupDual orexin receptor antagonistTreatment efficacyHypnotics and sedativesInsomnia disorderLemborexant |
| spellingShingle | Amitabh Dash Kate Pinner Yuichi Inoue Kenichi Hayashida Sung Chul Lim Chang-Ho Yun Tsuo-Hung Lan Chieh-Liang Huang Jane Yardley Naoki Kubota Margaret Moline Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder Sleep Medicine: X Asian continental ancestry group Dual orexin receptor antagonist Treatment efficacy Hypnotics and sedatives Insomnia disorder Lemborexant |
| title | Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder |
| title_full | Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder |
| title_fullStr | Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder |
| title_full_unstemmed | Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder |
| title_short | Efficacy and safety of lemborexant over 12 months in Asian adults with insomnia disorder |
| title_sort | efficacy and safety of lemborexant over 12 months in asian adults with insomnia disorder |
| topic | Asian continental ancestry group Dual orexin receptor antagonist Treatment efficacy Hypnotics and sedatives Insomnia disorder Lemborexant |
| url | http://www.sciencedirect.com/science/article/pii/S2590142722000039 |
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