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Meta-analysis

Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis

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Pages 1237-1251 | Received 17 Feb 2023, Accepted 05 Jun 2023, Published online: 07 Aug 2023

References

  • Colrain IM Sleep and the brain. Neuropsychol rev. 2011 Mar;21(1):1–4. doi: 10.1007/s11065-011-9156-z
  • Khaled SM, Petcu C, Al-Thani MA, et al. Prevalence and associated factors of DSM-5 insomnia disorder in the general population of qatar. BMC Psychiatry. 2021 Feb 8;21(1):84. doi: 10.1186/s12888-020-03035-8
  • Morin CM, Drake CL, Harvey AG, et al. Insomnia disorder. Nat Rev Dis Primers. 2015 Sep 3;1(1):15026. doi: 10.1038/nrdp.2015.26
  • Bhaskar S, Hemavathy D, Prasad S Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family Med Prim Care. 2016 Oct;5(4):780–784. doi: 10.4103/2249-4863.201153
  • Dopheide JA. Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. Am J Manag Care. 2020 Mar;26(4 Suppl):S76–s84.
  • Worley SL The extraordinary importance of sleep: the detrimental effects of inadequate sleep on health and public safety drive an explosion of sleep research. Phar Ther. 2018 Dec;43(12):758–763. doi: 10.5664/jcsm.7176
  • Williams J, Roth A, Vatthauer K, et al. Cognitive behavioral treatment of insomnia. Chest. 2013 Feb 1;143(2):554–565. doi: 10.1378/chest.12-0731
  • Liu MT. Current and emerging therapies for insomnia. Am J Manag Care. 2020 Mar;26(4 Suppl):S85–s90.
  • Abad VC, Guilleminault C Insomnia in elderly patients: recommendations for pharmacological management. Drugs Aging. 2018 Sep;35(9):791–817. doi: 10.1007/s40266-018-0569-8
  • Lie JD, Tu KN, Shen DD, et al. Pharmacological treatment of Insomnia. Phar Ther. 2015 Nov;40(11):759–771. doi: 10.1176/appi.books.9780890425596.dsm12
  • Zammit G, Dauvilliers Y, Pain S, et al. Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder. Neurology. 2020 May 26;94(21):e2222–e32. doi: 10.1212/WNL.0000000000009475
  • Jacobson LH, Hoyer D, de Lecea L Hypocretins (orexins): the ultimate translational neuropeptides. J Intern Med. 2022 May;291(5):533–556. doi: 10.1111/joim.13406
  • Roch C, Bergamini G, Steiner MA, et al. Nonclinical pharmacology of daridorexant: a new dual orexin receptor antagonist for the treatment of insomnia. Psychopharmacology. 2021 Oct;238(10):2693–2708. doi: 10.1007/s00213-021-05954-0
  • Markham A Daridorexant: first approval. Drugs. 2022 Apr;82(5):601–607. doi: 10.1007/s40265-022-01699-y
  • Idorsia Pharmaceuticals Ltd: Europe’s first dual orexin receptor antagonist – Daridorexant (QUVIVIQ) – granted approval to improve both nighttime symptoms and daytime functioning in adults with chronic insomnia disorder [Internet]. 2022 May 3 [cited May 16, 2023]. Available from: https://finance.yahoo.com/news/europe-first-dual-orexin-receptor-050000256.html
  • US FDA. Daridorexant (“QUVIVIQ”) tablets, for oral use controlled substance schedule pending]; Initial U.S. Approval: [pending controlled substance scheduling] 2022. [[updated 2022; cited 2022 Jul 22]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214985s000lbl.pdf
  • Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane collaboration’s tool for assessing risk of bias in randomised trials. BMJ (Clin Res Ed). 2011 Oct 18;343:d5928. doi: 10.1136/bmj.d5928
  • Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ (Clin Res Ed). 2019 Aug 28;366:l4898. doi: 10.1136/bmj.l4898
  • McGuinness LA, Higgins JPT. Risk-of-bias visualization (robvis): An R package and shiny web app for visualizing risk-of-bias assessments. Res Synth Methods. 2020 2020 Apr 26;12:55–61. doi: 10.1002/jrsm.1411
  • McMaster University and Evidence Prime. Gradepro GDT: GRADEpro guideline development tool [software]. [ cited 2022 Sep 22]. Available from: gradepro.org
  • Schünemann HB, Guyatt G, Oxman A GRADE handbook for grading quality of evidence and strength of recommendations. 2013 [cited 2022 Sep 22]. Available from: guidelinedevelopment.org/handbook.
  • The Cochrane Collaboration. Cochrane training Cochrane review manager (RevMan) 2022. [updated 2022; cited 2022 Jul 28]. Available from: https://training.cochrane.org/online-learning/core-software/revman
  • The Cochrane Collaboration. Heterogeneity: Cochrane Training Cochrane Handbook for Systematic Reviews of Interventions. 2022 [updated 2022; cited 2022 Jul 29]. Available from: https://training.cochrane.org/handbook/current/chapter-10#section-10-10
  • The Cochrane Collaboration. Fixed or random effects? Cochrane training Cochrane handbook for systematic reviews of interventions. 2022 [updated 2022; cited 2022 Aug 1]. Available from: https://training.cochrane.org/handbook/current/chapter-10#section-10-10-4-1
  • Efficacy and safety of ACT-541468 in adult subjects with insomnia disorder (NCT02839200) [Internet]. 2020 [cited Aug 2, 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT02839200
  • Study to assess the efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder (NCT03545191) [Internet]. ClinicalTrials.gov. 2022 [cited Aug 2, 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT03545191
  • Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep(NCT03679884) [Internet]. 2022 [cited Aug 2, 2022]. Available from: https://clinicaltrials.gov/ct2/show/results/NCT03679884
  • Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep(NCT03575104) [Internet]. 2022 [cited Aug 2, 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT03575104
  • Dauvilliers Y, Zammit G, Fietze I, et al. Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder. Ann Neurol. 2020 Mar;87(3):347–356. doi: 10.1002/ana.25680. Erratum in: Ann Neurol. 2020 Sep;88(3):647-651.
  • Dos Santos JBR, da Silva MRR, da Silva MRR Daridorexant for the treatment of insomnia disorder: findings and implications. Eur J Clin Pharmacol. 2022 Sep 13;78(11):1749–1761. doi: 10.1007/s00228-022-03381-4
  • Mignot E, Mayleben D, Fietze I, et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125–139. doi: 10.1016/S1474-4422(21)00436-1
  • Schilling U, Henrich A, Muehlan C, et al. Impact of Daridorexant, a Dual Orexin Receptor Antagonist, on Cardiac Repolarization Following Bedtime Dosing: Results from a Thorough QT Study Using Concentration-QT Analysis. Clin Drug Investig. 2021 Aug;41(8):711–721. doi: 10.1007/s40261-021-01062-1
  • Fietze I, Bassetti CLA, Mayleben DW, et al. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct 01;39(10):795–810.
  • Muehlan C, Brooks S, Vaillant C, et al. Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator. Clin Pharmacol Ther. 2022 Jun;111(6):1334–1342. doi: 10.1002/cpt.2592
  • Ufer M, Kelsh D, Schoedel KA, et al. Abuse potential assessment of the new dual orexin receptor antagonist daridorexant in recreational sedative drug users as compared to suvorexant and zolpidem. Sleep. 2022 Mar 14;45(3). doi: 10.1093/sleep/zsab224
  • Glass J, Lanctôt KL, Herrmann N, et al. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ (Clin Res Ed). 2005 Nov 19;331(7526):1169. doi: 10.1136/bmj.38623.768588.47
  • Muehlan C, Heuberger J, Juif P-E, et al. Accelerated Development of the Dual Orexin Receptor Antagonist ACT-541468: Integration of a Microtracer in a First-in-Human Study. Clin Pharmacol Ther. 2018;104(5):1022–1029. doi: 10.1002/cpt.1046
  • Winkler A, Auer C, Doering BK, et al. Drug treatment of primary insomnia: a meta-analysis of polysomnographic randomized controlled trials. CNS Drugs. 2014 Sep;28(9):799–816. doi: 10.1007/s40263-014-0198-7
  • Ehlers CL, Benedict J, Wills D, et al. PSPH-D-18-00526: Effect of a dual orexin receptor antagonist (DORA-12) on sleep and event-related oscillations in rats exposed to ethanol vapor during adolescence. Psychopharmacol (Berl). 2020 Oct;237(10):2917–2927. doi: 10.1007/s00213-019-05371-4
  • Lee MG, Hassani OK, Jones BE Discharge of identified orexin/hypocretin neurons across the sleep-waking cycle. J Neurosci. 2005 Jul 13;25(28):6716–6720. doi: 10.1523/JNEUROSCI.1887-05.2005
  • Parks GS, Warrier DR, Dittrich L, et al. The Dual Hypocretin Receptor Antagonist Almorexant is Permissive for Activation of Wake-Promoting Systems. Neuropsychopharmacology. 2016 Mar;41(4):1144–1155. doi: 10.1038/npp.2015.256
  • Scammell TE, Arrigoni E, Lipton JO Neural Circuitry of Wakefulness and Sleep. Neuron. 2017 Feb 22;93(4):747–765. doi: 10.1016/j.neuron.2017.01.014
  • Robinson CL, Supra R, Downs E, et al. Daridorexant for the Treatment of Insomnia. Health Psychol Res. 2022;10(3):37400. doi: 10.52965/001c.37400
  • Albadrani MS, Albadrani MS, Fadlalmola HA, et al. Safety and efficacy of daridorexant in the treatment of insomnia: a systematic review and meta-analysis of randomized controlled trials. Int Clin Psychopharmacol. 2023 Jan 1;38(1):57–65. doi: 10.1097/YIC.0000000000000425
  • Mangoni AA, Jackson SH Age-related changes in pharmacokinetics and pharmacodynamics: basic principles and practical applications. Br J Clin Pharmacol. 2004 Jan;57(1):6–14. doi: 10.1046/j.1365-2125.2003.02007.x
  • Boof ML, Ufer M, Fietze I, et al. Assessment of the effect of the dual orexin receptor antagonist daridorexant on various indices of disease severity in patients with mild to moderate obstructive sleep apnea. Sleep Med. 2022 Apr;92:4–11.
  • Ziemichód W, Grabowska K, Kurowska A, et al. A Comprehensive Review of Daridorexant, a Dual-Orexin Receptor Antagonist as New Approach for the Treatment of Insomnia. Molecules. 2022 Sep 16;27(18):6041. doi: 10.3390/molecules27186041

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