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Authors
Fietze, Ingo
Bassetti, Claudio L. A.
Mayleben, David W.
Pain, Scott
Seboek Kinter, Dalma
McCall, William V. http://orcid.org/0000-0001-5035-7858
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03545191 at ClinicalTrials.govDocuments that mention this clinical trial
Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem
https://doi.org/10.1007/s40263-023-01020-9
Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant
https://doi.org/10.1007/s40290-023-00484-w
Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial
https://doi.org/10.1007/s40266-022-00977-4
P4 Daridorexant improves total sleep time (TST) in insomnia patients without altering the proportion of sleep stages
https://doi.org/10.1136/bmjresp-2023-bssconf.15
What place for daridorexant?
https://doi.org/10.1136/dtb.2023.000037
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Funding
Funding for this research was provided by:
Idorsia Pharmaceuticals
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Article History
Accepted: 6 September 2022
First Online: 13 September 2022
Declarations
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: This study was supported by Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland. Idorsia funded the medical writing support (manuscript preparation).
: IF reports consulting fees from Bayer, Bioproject, Hennig, Idorsia Pharmaceuticals, Jazz Pharmaceuticals, and STADA and speaker activity/reimbursement from Hennig, Idorsia Pharmaceuticals and Medice. CLAB reports consultancy fees from Bioproject, Takeda and Jazz Pharmaceuticals during the conduct of the trials. DM has been a clinical investigator for Apnimed, Eisai, Idorsia Pharmaceuticals, Imbrium, Janssen, Jazz Pharmaceuticals, Merck, Sage, Takeda and Vanda. WVM reports scientific advisor fees from Idorsia Pharmaceuticals and Janssen, and royalties from Wolter Kluwer. DSK and SP are employees of Idorsia Pharmaceuticals. IDSIQ was developed by Buysse DJ, Thompson W, Scott J, Franzen PL, Germain A Hall M, Moul DE, Nofzinger EA and Kupfer DJ of the University of Pittsburgh and as amended by Idorsia Pharmaceuticals Ltd. IDSIQ© 2020, University of Pittsburg. All rights reserved. IDSIQ-14 derivative created 2020 by Idorsia Pharmaceuticals Ltd under license and distributed by Idorsia Pharmaceuticals Ltd under license.
: The study protocol was approved by the appropriate institutional review boards or independent ethics committees and the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
: All patients provided written informed consent.
: Not applicable.
: The study sponsor will receive requests for individual participant data that underlie the results reported in this article, after deidentification, from researchers who provide a methodologically sound proposal. Please direct any requests to medicalinformationus@idorsia.com.
: Not applicable.
: All authors were involved in the study conceptualisation. DSK and SP were involved in data curation. SP was involved in the formal analysis. SP, DSK and IF were involved in the methodology. DSK was involved in supervision. SP was involved in validation and visualisation. IF, DWM and CLAB were trial investigators or participated in the conduct of the study. SP and DSK verified the data. All authors had full access to the data, were involved with review and editing of the manuscript, approved the final version of the manuscript and had final responsibility for the decision to submit for publication and agreed to be accountable for the work.
