Potential Aggravation of Suicide Risk With Daridorexant: Currently Not Enough Data to Show a Link

References (15)

1. Nobile B, Olié E, Courtet P. Possible suicidal risk with daridorexant, a new treatment for insomnia. J Clin Psychiatry. 2022;84(1):22l14628. PubMed CrossRef
2. Hertenstein E, Feige B, Gmeiner T, et al. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019;43:96–105. PubMed CrossRef
3. Geoffroy PA, Oquendo MA, Courtet P, et al. Sleep complaints are associated with increased suicide risk independently of psychiatric disorders: results from a national 3-year prospective study. Mol Psychiatry. 2021;26(6):2126–2136. PubMed CrossRef
4. Romier A, Maruani J, Lopez-Castroman J, et al. Objective sleep markers of suicidal behaviors in patients with psychiatric disorders: a systematic review and meta-analysis. Sleep Med Rev. 2023;68:101760. PubMed CrossRef
5. Palagini L, Hertenstein E, Riemann D, et al. Sleep, insomnia and mental health. J Sleep Res. 2022;31(4):e13628. PubMed CrossRef
6. Mignot E, Mayleben D, Fietze I, et al; investigators. 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;21(2):125–139. PubMed CrossRef
7. US Food and Drug Administration. Center for Drug Evaluation and Research. Risk Assessment and Risk Mitigation Review(s). US Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214985Orig1s000RiskR.pdf. January 2022.
8. Kunz D, Dauvilliers Y, Benes H, et al. Long-term safety and tolerability of daridorexant in patients with insomnia disorder. CNS Drugs. 2023;37(1):93–106. PubMed
9. European Medicines Agency. Assessment report on Quviviq. EMA/187589/2022. Published February 24, 2022. https://www.ema.europa.eu/en/documents/assessment-report/quviviq-epar-public-assessment-report_en.pdf >
10. Feng P, Hu Y, Vurbic D, et al. Chromosome 1 replacement increases brain orexins and antidepressive measures without increasing locomotor activity. J Psychiatr Res. 2014;59:140–147. PubMed CrossRef
11. Brundin L, Petersén A, Björkqvist M, et al. Orexin and psychiatric symptoms in suicide attempters. J Affect Disord. 2007;100(1-3):259–263. PubMed CrossRef
12. Fagan H, Jones E, Baldwin DS. Orexin receptor antagonists in the treatment of depression: a leading article summarising pre-clinical and clinical studies. CNS Drugs. 2023;37(1):1–12. PubMed CrossRef
13. Han Y, Yuan K, Zheng Y, et al. Orexin receptor antagonists as emerging treatments for psychiatric disorders. Neurosci Bull. 2020;36(4):432–448. PubMed CrossRef
14. Li H, Lu J, Li S, et al. Increased hypocretin (orexin) plasma level in depression, bipolar disorder patients. Front Psychiatry. 2021;12:676336. PubMed CrossRef
15. Palagini L, Geoffroy PA, Balestrieri M, et al. Current models of insomnia disorder: a theoretical review on the potential role of the orexinergic pathway with implications for insomnia treatment. J Sleep Res. 2023;14:e13825. PubMed CrossRef