Evaluating lemborexant for the treatment of insomnia

References

• American Psychiatric Association. Sleep-Wake Disorders. In: Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition (DSM-5) ed. Arlington, VA: American Psychiatric Association; 2013;361.
   Google Scholar
• Walsh JK, Coulouvrat C, Hajak G, et al. Nighttime insomnia symptoms and perceived health in the America Insomnia Survey (AIS). Sleep. 2011;34(8):997–1011.
   PubMed Web of Science ®Google Scholar
• Dopheide JA. Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. Am J Manag Care. 2020;26(4 Suppl):S76–S84.
   PubMed Web of Science ®Google Scholar
• Krystal AD, Prather AA, Ashbrook LH. The assessment and management of insomnia: an update. World Psychiatry. 2019;18(3):337–352.
   PubMed Web of Science ®Google Scholar
• Riemann D, Baglioni C, Bassetti C, et al. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017;26(6):675–700.
   PubMed Web of Science ®Google Scholar
• Morin CM, Belanger L, LeBlanc M, et al. The natural history of insomnia: a population-based 3-year longitudinal study. Arch Intern Med. 2009;169(5):447–453.
   PubMedGoogle Scholar
• LeBlanc ES, Smith NX, Nichols GA, et al. Insomnia is associated with an increased risk of type 2 diabetes in the clinical setting. BMJ Open Diabetes Res Care. 2018;6(1):e000604.
   PubMed Web of Science ®Google Scholar
• Javaheri S, Redline S. Insomnia and risk of cardiovascular disease. Chest. 2017;152(2):435–444.
   PubMed Web of Science ®Google Scholar
• Yamamoto R, Shinzawa M, Isaka Y, et al. Sleep quality and sleep duration with CKD are associated with progression to ESKD. Clin J Am Soc Nephrol. 2018;13(12):1825–1832.
   PubMed Web of Science ®Google Scholar
• Shamim SA, Warriach ZI, Tariq MA, et al. Insomnia: risk factor for neurodegenerative diseases. Cureus. 2019;11(10):e6004.
   PubMed Web of Science ®Google Scholar
• Pigeon WR, Bishop TM, Krueger KM. Insomnia as a precipitating factor in new onset mental illness: a systematic review of recent findings. Curr Psychiatry Rep. 2017;19(8):44.
   PubMed Web of Science ®Google Scholar
• Li L, Wu C, Gan Y, et al. Insomnia and the risk of depression: a meta-analysis of prospective cohort studies. BMC Psychiatry. 2016;16(1):375.
   PubMed Web of Science ®Google Scholar
• Angarita GA, Emadi N, Hodges S, et al. Sleep abnormalities associated with alcohol, cannabis, cocaine, and opiate use: a comprehensive review. Addict Sci Clin Pract. 2016;11(1):9.
   PubMedGoogle Scholar
• Qaseem A, Kansagara D, Forciea MA, et al., Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2016;165(2):125–133.
   PubMedGoogle Scholar
• Haynes J, Talbert M, Fox S, et al. Cognitive behavioral therapy in the treatment of insomnia. South Med J. 2018;111(2):75–80.
   PubMed Web of Science ®Google Scholar
• Williams J, Roth A, Vatthauer K, et al. Cognitive behavioral treatment of insomnia. Chest. 2013;143(2):554–565.
   PubMed Web of Science ®Google Scholar
• Jan Y-W, Yang C-M, Huang S-H, et al. Treatment effect of cognitive-behavior therapy for insomnia combined with usual medication. Sleep Biol Rhythms. 2019;17(3):311–321.
   Web of Science ®Google Scholar
• Do D. Trends in the use of medications with insomnia side effects and the implications for insomnia among US adults. J Sleep Res. 2020;29:e13075.
   PubMedGoogle Scholar
• Sateia MJ, Buysse DJ, Krystal AD, et al. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017;13(2):307–349.
   PubMed Web of Science ®Google Scholar
• Liu MT. Current and emerging therapies for insomnia. Am J Manag Care. 2020;26(4 Suppl):S85–S90.
   PubMed Web of Science ®Google Scholar
• Holbrook AM, Crowther R, Lotter A, et al. Meta-analysis of benzodiazepine use in the treatment of insomnia. CMAJ. 2000;162(2):225–233.
   PubMed Web of Science ®Google Scholar
• Pfizer Inc. Halcion (triazolam) Product Information. 2016.
   Google Scholar
• Mallinckrodt. Restoril (temazepam) Product Information. 2016.
   Google Scholar
• de las Cuevas C, Sanz E, de la Fuente J. Benzodiazepines: more “behavioural” addiction than dependence. Psychopharmacology. 2003;167(3):297–303.
   PubMed Web of Science ®Google Scholar
• Lader M. Benzodiazepine harm: how can it be reduced? Br J Pharmacol. 2012;77(2):295–301.
   Web of Science ®Google Scholar
• Nicholson AN. The use of short- and long-acting hypnotics in clinical medicine. Br J Clin Pharmacol. 1981;11(Suppl S1):61S–69S.
   PubMedGoogle Scholar
• Bertisch SM, Herzig SJ, Winkelman JW, et al. National use of prescription medications for insomnia: NHANES 1999-2010. Sleep. 2014;37(2):343–349.
   PubMed Web of Science ®Google Scholar
• King Pharmaceuticals Inc. Sonata (zaleplon) Product Information. 2007.
   Google Scholar
• Sunavion Pharmaceuticals Inc. Lunesta (eszopiclone) Product Information. 2014.
   Google Scholar
• Sanofi-Aventis US LLC. Ambien (zolpidem) Product Information. 2014.
   Google Scholar
• Nutt DJ, Stahl SM. Searching for perfect sleep: the continuing evolution of GABA A receptor modulators as hypnotics. J Psychopharmacol. 2010;24(11):1601–1612.
   PubMed Web of Science ®Google Scholar
• Huedo-Medina TB, Kirsch I, Middlemass J, et al. Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration. BMJ. 2012;345:e8343.
   PubMed Web of Science ®Google Scholar
• Krystal AD, Walsh JK, Laska E, et al. Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep. 2003;26(7):793–799.
   PubMed Web of Science ®Google Scholar
• Yu N-W, Chen P-J, Tsai H-J, et al. Association of benzodiazepine and Z-drug use with the risk of hospitalisation for fall-related injuries among older people: a nationwide nested case–control study in Taiwan. BMC Geriatr. 2017;17(1):140.
   PubMedGoogle Scholar
• FDA Drug Safety Communication. FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines. [cited 2020 Aug 18]. Available from: https://wwwfdagov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia. 2019.
   Google Scholar
• Doghramji PP. Insomnia: zolpidem extended-release for the treatment of sleep induction and sleep maintenance symptoms. MedGenMed. 2007;9(1):11.
   PubMedGoogle Scholar
• Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006;63(10):1149–1157.
   PubMed Web of Science ®Google Scholar
• Andersen LPH, Gögenur I, Rosenberg J, et al. The safety of melatonin in humans. Clin Drug Investig. 2016;36(3):169–175.
   PubMed Web of Science ®Google Scholar
• Gray C, Ryce A. Melatonin for the treatment of insomnia: a review of clinical effectiveness, cost-effectiveness, and guidelines Ottawa, Canada: CADTH; 2019 [cited 2020 Aug 18]. Available from: https://cadth.ca/melatonin-insomnia-review-clinical-effectiveness-cost-effectiveness-and-guidelines
   Google Scholar
• Neurim Pharmaceuticals. Circadin Product Information. 2016.
   Google Scholar
• Maras A, Schroder CM, Malow BA, et al. Long-term efficacy and safety of pediatric prolonged-release melatonin for insomnia in children with autism spectrum disorder. J Child Adolesc Psychopharmacol. 2018;28(10):699–710.
   PubMed Web of Science ®Google Scholar
• Katwala J, Kumar AK, Sejpal JJ, et al. Therapeutic rationale for low dose doxepin in insomnia patients. Asian Pac J Trop Dis. 2013;3(4):331–336.
   Google Scholar
• Janto K, Prichard JR, Pusalavidyasagar S. An update on dual orexin receptor antagonists and their potential role in insomnia therapeutics. J Clin Sleep Med. 2018;14(8):1399–1408.
   PubMed Web of Science ®Google Scholar
• Merck & Co, Inc. Belsomra (suvorexant) Product Information. 2014.
   Google Scholar
• Kishi T, Matsunaga S, Iwata N. Suvorexant for primary insomnia: a systematic review and meta-analysis of randomized placebo-controlled trials. PLoS One. 2015;10(8):e0136910.
   PubMed Web of Science ®Google Scholar
• Rosenberg R, Murphy P, Zammit G, et al., Comparison of lemborexant with placebo and zolpidem tartrate extended release for the treatment of older adults with insomnia disorder: a phase 3 randomized clinical trial. JAMA Network Open. 2019;2(12):e1918254.
   PubMed Web of Science ®Google Scholar
• Dauvilliers Y, Zammit G, Fietze I, et al. Daridorexant, a new dual orexin receptor antagonist to treat insomnia disorder. Ann Neurol. 2020;87(3):347–356.
   PubMed Web of Science ®Google Scholar
• De Boer P, Drevets WC, Rofael H, et al. A randomized phase 2 study to evaluate the orexin-2 receptor antagonist seltorexant in individuals with insomnia without psychiatric comorbidity. J Psychopharmacol. 2018;32(6):668–677.
   PubMed Web of Science ®Google Scholar
• Boafo A, Greenham S, Sullivan M, et al. Medications for sleep disturbance in children and adolescents with depression: a survey of Canadian child and adolescent psychiatrists. Child Adolesc Psychiatry Ment Health. 2020;14(1):10.
   PubMed Web of Science ®Google Scholar
• Yoshida Y, Naoe Y, Terauchi T, et al. Discovery of (1R,2S)-2-{[(2,4-Dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropanecarboxamide (E2006): a potent and efficacious oral orexin receptor antagonist. J Med Chem. 2015;58(11):4648–4664.
   PubMed Web of Science ®Google Scholar
• Eisai. Dayvigo (lemborexant) product information. 2019.
   Google Scholar
• Beuckmann CT, Suzuki M, Ueno T, et al. In vitro and in silico characterization of lemborexant (E2006), a novel dual orexin receptor antagonist. J Pharmacol Exp Ther. 2017;362(2):287–295.
   PubMed Web of Science ®Google Scholar
• Ueno T, Ishida T, Kusano K. Disposition and metabolism of [14C]lemborexant, a novel dual orexin receptor antagonist, in rats and monkeys. Xenobiotica. 2019;49(6):688–697.
   PubMed Web of Science ®Google Scholar
• Landry I, Nakai K, Ferry J, et al. Pharmacokinetics, pharmacodynamics, and safety of the dual orexin receptor antagonist lemborexant: findings from single-dose and multiple-ascending-dose phase 1 studies in healthy adults. Clin Pharmacol Drug Dev. 2021;10(2):153–165.
   PubMed Web of Science ®Google Scholar
• Lalovic B, Majid O, Aluri J, et al. Population pharmacokinetics and exposure-response analyses for the most frequent adverse events following treatment with lemborexant, an orexin receptor antagonist, in subjects with insomnia disorder. J Clin Pharmacol. 2020;60(12):1642–1654.
   PubMed Web of Science ®Google Scholar
• Murphy P, Moline M, Mayleben D, et al. Lemborexant, a dual orexin receptor antagonist (DORA) for the treatment of insomnia disorder: results from a Bayesian, adaptive, randomized, double-blind, placebo-controlled study. J Clin Sleep Med. 2017;13(11):1289–1299.
   PubMed Web of Science ®Google Scholar
• Kärppä M, Yardley J, Pinner K, et al. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020;43(9). 10.1093/sleep/zsaa123.
   PubMed Web of Science ®Google Scholar
• Sutton EL. Profile of suvorexant in the management of insomnia. Drug Des Devel Ther. 2015;9:6035–6042.
   PubMed Web of Science ®Google Scholar
• Mahoney CE, Mochizuki T, Scammell TE. Dual orexin receptor antagonists increase sleep and cataplexy in wild type mice. Sleep. 2020;43(6):zsz302.
   PubMed Web of Science ®Google Scholar
• McCall WV, Benca RM, Rosenquist PB, et al. Hypnotic medications and suicide: risk, mechanisms, mitigation, and the FDA. Am J Psychiatry. 2017;174(1):18–25.
   PubMed Web of Science ®Google Scholar
• Murphy P, Kumar D, Zammit G, et al. Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening. J Clin Sleep Med. 2020;16(5):765–773.
   PubMed Web of Science ®Google Scholar
• Vermeeren A, Jongen S, Murphy P, et al. On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. Sleep. 2019;42(4):zsy260.
   PubMed Web of Science ®Google Scholar
• Cheng JY, Filippov G, Moline M, et al. Respiratory safety of lemborexant in healthy adult and elderly subjects with mild obstructive sleep apnea: a randomized, double-blind, placebo-controlled, crossover study. J Sleep Res. 2020;29(4):e13021.
   PubMed Web of Science ®Google Scholar
• Moline M, Zammit G, Yardley J, et al. Lack of residual morning effects of lemborexant treatment for insomnia: summary of findings across 9 clinical trials. Postgrad Med. 2021;133(1):71–81.
   PubMed Web of Science ®Google Scholar
• Krystal AD, Lankford A, Durrence HH, et al. Efficacy and safety of doxepin 3 and 6 mg in a 35-day sleep laboratory trial in adults with chronic primary insomnia. Sleep. 2011;34(10):1433–1442.
   PubMed Web of Science ®Google Scholar
• Valentino RJ, Volkow ND. Drugs, sleep, and the addicted brain. Neuropsychopharmacology. 2020;45(1):3–5.
   PubMed Web of Science ®Google Scholar
• Zarrabian S, Riahi E, Karimi S, et al. The potential role of the orexin reward system in future treatments for opioid drug abuse. Brain Res. 2020;1731:146028.
   PubMed Web of Science ®Google Scholar
• Kishi T, Nomura I, Matsuda Y, et al. Lemborexant vs suvorexant for insomnia: a systematic review and network meta-analysis. J Psychiatr Res. 2020;128:68–74.
   PubMed Web of Science ®Google Scholar