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Article History

Accepted: 26 November 2024

First Online: 20 March 2025

Declarations

:

: This article has been published as part of a journal supplement wholly funded by Avadel Pharmaceuticals (Chesterfield, MO, USA). This study was funded by Avadel Pharmaceuticals. Avadel Pharmaceuticals was involved in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Open access publication and publication costs were funded by Avadel Pharmaceuticals.

: L.K. is a consultant for and/or has served on advisory boards for Avadel Pharmaceuticals, Harmony Biosciences, and Takeda. A.R. has received grant/research support from Jazz Pharmaceuticals, Suven, Inspire, Nyxoah, LivaNova, and Avadel Pharmaceuticals; is a consultant for Jazz Pharmaceuticals, Suven, Inspire, and Avadel Pharmaceuticals; and has served on speakers’ bureaus for Jazz Pharmaceuticals and Eisai. J.W.W. has received consultation fees from Avadel Pharmaceuticals, Emalex Biosciences, Noctrix Health, Disc Medicine, and Idorsia Pharmaceuticals; and research support from Merck & Co., American Regent, NIDA, the RLS Foundation, and the Baszucki Brain Research Fund. J.W.W. is an Editorial Board member of CNS Drugs. J.W.W. was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. A.M.M. has served as a consultant, speaker, and/or on advisory boards for Avadel Pharmaceuticals, Eisai, Harmony Biosciences, Jazz Pharmaceuticals, Alkermes, and Takeda Pharmaceutical Co; has received grant funding from National Institutes of Health, UCB Pharmaceuticals, Jazz Pharmaceuticals, ResMed Foundation, Coverys Foundation, Harmony Biosciences, and Geisinger Health Plan; is the CEO of DAMM Good Sleep, LLC; and serves as an advisor for Neura Health and Floraworks. J.G. is an employee of Avadel Pharmaceuticals.

: Institutional review board or independent ethics committee approval was obtained for each study center.

: Written informed consent was provided by all adult participants (≥ 18 years old); consent was obtained from both the participant and their legally authorized representative for participants 16 and 17 years of age.

: Not applicable

: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

: Not applicable.

: L.K.: writing—review and editing, and formal analysis. A.R.: writing—review and editing, and formal analysis. J.W.W.: writing—review and editing, and formal analysis. A.M.M.: writing—review and editing, and formal analysis. J.G.: writing—review and editing, and formal analysis. All authors have read and approved the final submitted manuscript and have agreed to be accountable for the work.