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Effect of discontinuation of lemborexant following long-term treatment of insomnia disorder: Secondary analysis of a randomized clinical trial
http://hdl.handle.net/20.500.12000/0002019937
http://hdl.handle.net/20.500.12000/00020199374454bf27-5ff6-4bf0-a2f0-deb6752d74d3
| 名前 / ファイル | ライセンス | アクション |
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T_No16p581.pdf (194 KB)
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| Item type | 琉球大学リポジトリ登録用アイテムタイプ(1) | |||||||||||||||||||
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| 公開日 | 2023-07-18 | |||||||||||||||||||
| タイトル | ||||||||||||||||||||
| タイトル | Effect of discontinuation of lemborexant following long-term treatment of insomnia disorder: Secondary analysis of a randomized clinical trial | |||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 作成者 |
Takaesu, Yoshikazu
× Takaesu, Yoshikazu
× Suzuki, Masahiro
× Margaret, Moline
× Kate, Pinner
× Inabe, Kanako
× Nishi, Yurie
× Kuriyama, Kenichi
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| アクセス権 | ||||||||||||||||||||
| アクセス権 | open access | |||||||||||||||||||
| アクセス権URI | http://purl.org/coar/access_right/c_abf2 | |||||||||||||||||||
| 権利情報 | ||||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 権利情報 | © 2022 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. | |||||||||||||||||||
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| 言語 | en | |||||||||||||||||||
| 権利情報Resource | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |||||||||||||||||||
| 権利情報 | This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License | |||||||||||||||||||
| 内容記述 | ||||||||||||||||||||
| 内容記述タイプ | Abstract | |||||||||||||||||||
| 内容記述 | Discontinuing long-term pharmacotherapy for insomnia can result in rebound insomnia or withdrawal symptoms and suboptimal treatment. Post hoc analyses evaluated rebound insomnia and withdrawal symptoms among the subset of subjects from a phase III, 12-month, global, multicenter, randomized, double-blind, parallel-group study who completed 12 or 6 months of active treatment and follow-up period. Study E2006-G000- 303 (Study 303) included adults (N = 655) with subjective sleep-onset latency ≥30 min and/or subjective wake-after- sleep onset ≥60 min at least three times weekly during the 4 weeks before enrollment. Subjects were randomized 1:1:1 to lemborexant 5 mg (LEM5) or 10 mg (LEM10) or placebo for 6 months. Thereafter, for an additional 6 months, LEM5-and LEM10-treated subjects continued lemborexant and the placebo group was rerandomized 1:1 to LEM5 or LEM10. Month 12 was followed by abrupt discontinuation and a 2-week end-of- study follow-up. Using daily electronic sleep diaries, patients reported (subjective) sleep end points (sleep-onset latency, wake-after- sleep onset, sleep efficiency, and total sleep time). Withdrawal symptoms were assessed using the Tyrer Benzodiazepine Withdrawal Symptoms Questionnaire (T-BWSQ). Sleep outcome improvements with lemborexant at month 12 were generally maintained throughout the 2-week off-treatment period wherein <20% of subjects experienced significant worsening of insomnia symptoms versus screening. There was no evidence of withdrawal symptoms by T-BWSQ following lemborexant discontinuation. This analysis demonstrates rebound insomnia is unlikely to occur with lemborexant, and its effectiveness is maintained after abrupt discontinuation without placebo replacement following 6–12 months of treatment. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Discontinuation of some hypnotic drugs can result in rebound insomnia or withdrawal. Rebound insomnia, which is usually temporary, may involve worsening of the insomnia originally being treated. WHAT QUESTION DID THIS STUDY ADDRESS? These post hoc analyses evaluated effects of treatment discontinuation in 6-to 12-month lemborexant-treated subjects (lemborexant 5 or 10 mg daily), followed by a 2-week follow-up period with no placebo replacement so clinicians could more easily interpret the safety data of lemborexant after discontinuation. These analyses also assessed the potential influence of lemborexant dose/treatment duration on the rate of sleep parameter worsening, along with what potential new adverse events might have emerged. WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? This analysis demonstrates rebound insomnia is unlikely to occur with lemborexant, and its effectiveness is maintained after abrupt discontinuation following 6–12 months of treatment. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? These findings suggest patients with insomnia can be treated with lemborexant long term without the fear of potential adverse effects of withdrawal and rebound insomnia reported for other insomnia pharmacotherapies. |
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| 言語 | en | |||||||||||||||||||
| 出版者 | ||||||||||||||||||||
| 出版者 | © 2022 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. | |||||||||||||||||||
| 言語 | en | |||||||||||||||||||
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| 言語 | eng | |||||||||||||||||||
| 資源タイプ | ||||||||||||||||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||||||||||||||||
| 資源タイプ | journal article | |||||||||||||||||||
| 出版タイプ | ||||||||||||||||||||
| 出版タイプ | VoR | |||||||||||||||||||
| 出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||||||||||||||||
| 関連情報 | ||||||||||||||||||||
| 識別子タイプ | DOI | |||||||||||||||||||
| 関連識別子 | https://doi.org/10.1111/cts.13470 | |||||||||||||||||||
| 収録物識別子 | ||||||||||||||||||||
| 収録物識別子タイプ | EISSN | |||||||||||||||||||
| 収録物識別子 | 1752-8062 | |||||||||||||||||||
| 収録物名 | ||||||||||||||||||||
| 収録物名 | Clinical and Translational Science | |||||||||||||||||||
| 言語 | en | |||||||||||||||||||
| 書誌情報 |
巻 16, 号 4, p. 581-592, 発行日 2022-12-23 |
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Takaesu, Yoshikazu, Suzuki, Masahiro, Margaret, Moline, Kate, Pinner, Inabe, Kanako, Nishi, Yurie, Kuriyama, Kenichi, n.d., Effect of discontinuation of lemborexant following long-term treatment of insomnia disorder: Secondary analysis of a randomized clinical trial: © 2022 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics., 581–592 p.
