{"created":"2023-07-18T07:16:59.751342+00:00","id":2019937,"links":{},"metadata":{"_buckets":{"deposit":"52872e28-a4d2-45c0-adf3-caf5d56b49c1"},"_deposit":{"created_by":8,"id":"2019937","owner":"8","owners":[8],"pid":{"revision_id":0,"type":"depid","value":"2019937"},"status":"published"},"_oai":{"id":"oai:u-ryukyu.repo.nii.ac.jp:02019937","sets":["1642838163960:1642838338003","1642838403551:1642838409905"]},"author_link":[],"item_1617186331708":{"attribute_name":"Title","attribute_value_mlt":[{"subitem_title":"Effect of discontinuation of lemborexant following long-term treatment of insomnia disorder: Secondary analysis of a randomized clinical trial","subitem_title_language":"en"}]},"item_1617186419668":{"attribute_name":"Creator","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Takaesu, Yoshikazu","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Suzuki, Masahiro","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Margaret, Moline","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Kate, Pinner","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Inabe, Kanako","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Nishi, Yurie","creatorNameLang":"en"}]},{"creatorNames":[{"creatorName":"Kuriyama, Kenichi","creatorNameLang":"en"}]}]},"item_1617186476635":{"attribute_name":"Access Rights","attribute_value_mlt":[{"subitem_access_right":"open access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_abf2"}]},"item_1617186499011":{"attribute_name":"Rights","attribute_value_mlt":[{"subitem_rights":"© 2022 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.","subitem_rights_language":"en"},{"subitem_rights":"This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License","subitem_rights_language":"en","subitem_rights_resource":"https://creativecommons.org/licenses/by-nc-nd/4.0/"}]},"item_1617186626617":{"attribute_name":"Description","attribute_value_mlt":[{"subitem_description":"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.\nStudy Highlights\nWHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?\nDiscontinuation 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.\nWHAT QUESTION DID THIS STUDY ADDRESS?\nThese 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.\nWHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?\nThis analysis demonstrates rebound insomnia is unlikely to occur with lemborexant, and its effectiveness is maintained after abrupt discontinuation following 6–12 months of treatment.\nHOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?\nThese 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.","subitem_description_language":"en","subitem_description_type":"Abstract"}]},"item_1617186643794":{"attribute_name":"Publisher","attribute_value_mlt":[{"subitem_publisher":"© 2022 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.","subitem_publisher_language":"en"}]},"item_1617186702042":{"attribute_name":"Language","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_1617186920753":{"attribute_name":"Source Identifier","attribute_value_mlt":[{"subitem_source_identifier":"1752-8062","subitem_source_identifier_type":"EISSN"}]},"item_1617186941041":{"attribute_name":"Source Title","attribute_value_mlt":[{"subitem_source_title":"Clinical and Translational Science","subitem_source_title_language":"en"}]},"item_1617187056579":{"attribute_name":"Bibliographic Information","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2022-12-23","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"4","bibliographicPageEnd":"592","bibliographicPageStart":"581","bibliographicVolumeNumber":"16"}]},"item_1617258105262":{"attribute_name":"Resource Type","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_1617265215918":{"attribute_name":"Version Type","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_1617353299429":{"attribute_name":"Relation","attribute_value_mlt":[{"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://doi.org/10.1111/cts.13470","subitem_relation_type_select":"DOI"}}]},"item_1617605131499":{"attribute_name":"File","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_access","date":[{"dateType":"Available","dateValue":"2023-07-18"}],"filename":"T_No16p581.pdf","filesize":[{"value":"194 KB"}],"url":{"url":"https://u-ryukyu.repo.nii.ac.jp/record/2019937/files/T_No16p581.pdf"},"version_id":"a637da2c-131d-4966-a7b0-2da647da571f"}]},"item_title":"Effect of discontinuation of lemborexant following long-term treatment of insomnia disorder: Secondary analysis of a randomized clinical trial","item_type_id":"59","owner":"8","path":["1642838338003","1642838409905"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2023-07-18"},"publish_date":"2023-07-18","publish_status":"0","recid":"2019937","relation_version_is_last":true,"title":["Effect of discontinuation of lemborexant following long-term treatment of insomnia disorder: Secondary analysis of a randomized clinical trial"],"weko_creator_id":"8","weko_shared_id":-1},"updated":"2025-02-18T11:20:10.772444+00:00"}