Academic Journal
Effect of discontinuation of lemborexant following long‐term treatment of insomnia disorder: Secondary analysis of a randomized clinical trial
| Title: | Effect of discontinuation of lemborexant following long‐term treatment of insomnia disorder: Secondary analysis of a randomized clinical trial |
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| Authors: | Yoshikazu Takaesu, Masahiro Suzuki, Margaret Moline, Kate Pinner, Kanako Inabe, Yurie Nishi, Kenichi Kuriyama |
| Source: | Clinical and Translational Science, Vol 16, Iss 4, Pp 581-592 (2023) |
| Publisher Information: | Wiley, 2023. |
| Publication Year: | 2023 |
| Collection: | LCC:Therapeutics. Pharmacology LCC:Public aspects of medicine |
| Subject Terms: | Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270 |
| More Details: | Abstract 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 |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1752-8062 1752-8054 |
| Relation: | https://doaj.org/toc/1752-8054; https://doaj.org/toc/1752-8062 |
| DOI: | 10.1111/cts.13470 |
| Access URL: | https://doaj.org/article/e3daed50698f49e49e0ccb649ef883aa |
| Accession Number: | edsdoj.3daed50698f49e49e0ccb649ef883aa |
| Database: | Directory of Open Access Journals |
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| ISSN: | 17528062 17528054 |
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| DOI: | 10.1111/cts.13470 |
| Published in: | Clinical and Translational Science |
| Language: | English |