133
Views
0
CrossRef citations to date
0
Altmetric
CLINICAL TRIAL REPORT

Assessing the Real-World, Long-Term Impact of Lemborexant on Sleep Quality in a Home-Based Clinical Study

ORCID Icon, ORCID Icon, ORCID Icon, , , , , , , ORCID Icon, , & show all
Pages 291-303 | Received 08 Nov 2023, Accepted 01 Mar 2024, Published online: 20 Mar 2024

References

  • Endomba FT, Tchebegna PY, Chiabi E, et al. Epidemiology of insomnia disorder in older persons according to the diagnostic and statistical manual of mental disorders: a systematic review and meta-analysis. Eur Geriatr Med. 2023;14(6):1261–1272. doi:10.1007/s41999-023-00862-2
  • Canever JB, Cândido LM, Moreira BS, et al. A nationwide study on sleep complaints and associated factors in older adults: ELSI-Brazil. Cad Saude Publica. 2023;39:e00061923. doi:10.1590/0102-311xen061923
  • Doi Y, Minowa M, Okawa M, Uchiyama M. Prevalence of sleep disturbance and hypnotic medication use in relation to sociodemographic factors in the general Japanese adult population. J Epidemiol. 2000;10(2):79–86. doi:10.2188/jea.10.79
  • Klink ME, Quan SF, Kaltenborn WT, Lebowitz MD. Risk factors associated with complaints of insomnia in a general adult population. Influence of previous complaints of insomnia. Arch Intern Med. 1992;152:1634–1637. doi:10.1001/archinte.1992.00400200070012
  • Lu JL, Freire AX, Molnar MZ, et al. Association of chronic insomnia with mortality and adverse renal outcomes. Mayo Clin Proc. 2018;93(11):1563–1570. doi:10.1016/j.mayocp.2018.05.032
  • 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:e000604.
  • de Almondes KM, Costa MV, Malloy-Diniz LF, et al. Insomnia and risk of dementia in older adults: systematic review and meta-analysis. J Psychiat Res. 2016;77:109–115. doi:10.1016/j.jpsychires.2016.02.021
  • Wu MP, Lin HJ, Weng SF, et al. Insomnia subtypes and the subsequent risks of stroke: report from a nationally representative cohort. Stroke. 2014;45(5):1349–1354. doi:10.1161/STROKEAHA.113.003675
  • Baglioni C, Battagliese G, Feige B, et al. Insomnia as a predictor of depression: a meta-analytic evaluation of longitudinal epidemiological studies. J Affect Disord. 2011;135(1–3):10–19. doi:10.1016/j.jad.2011.01.011
  • Garbarino S, Magnavita N, Guglielmi O, et al. Insomnia is associated with road accidents. Further evidence from a study on truck drivers. PLoS One. 2017;12:e0187256. doi:10.1371/journal.pone.0187256
  • Kessler RC, Berglund PA, Coulouvrat C, et al. Insomnia and the performance of US workers: results from the America insomnia survey. Sleep. 2011;34(9):1161–1171. doi:10.5665/SLEEP.1230
  • Miyata S, Noda A, Iwamoto K, et al. Poor sleep quality impairs cognitive performance in older adults. J Sleep Res. 2013;22(5):535–541. doi:10.1111/jsr.12054
  • Kato K, Miyata S, Ando M, et al. Influence of sleep duration on cortical oxygenation in elderly individuals. Psychiatry Clin Neurosci. 2017;71(1):44–51. doi:10.1111/pcn.12464
  • 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. doi:10.1111/jsr.12594
  • 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(02):307–349. doi:10.5664/jcsm.6470
  • Klotz U. Pharmacokinetics and drug metabolism in the elderly. Drug Metab Rev. 2009;41(2):67–76. doi:10.1080/03602530902722679
  • Tsuruta Y, Iwamoto K, Banno M, et al. Effects of hypnotics on prefrontal cortex activity during a verbal fluency task in healthy male subjects: a near-infrared spectroscopy study. Hum Psychopharmacol. 2018;33(6):e2678. doi:10.1002/hup.2678
  • Lou BX, Oks M. Insomnia: pharmacologic treatment. Clin Geriatr Med. 2021;37:401–415. doi:10.1016/j.cger.2021.04.003
  • De Crescenzo F, Gl D, Ostinelli EG, et al. Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis. Lancet. 2022;400:170–184. doi:10.1016/S0140-6736(22)00878-9
  • 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:e1918254. doi:10.1001/jamanetworkopen.2019.18254
  • Moline M, Zammit G, Cheng JY, et al. Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorder. J Clin Sleep Med. 2021;17(6):1167–1174. doi:10.5664/jcsm.9150
  • Clark JW, Brian ML, Drummond SPA, Hoyer D, Jacobson LH. Effects of orexin receptor antagonism on human sleep architecture: a systematic review. Sleep Med Rev. 2020;53:101332. doi:10.1016/j.smrv.2020.101332
  • 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:zsaa123. doi:10.1093/sleep/zsaa123
  • Mogavero MP, Silvani A, Lanza G, DelRosso LM, Ferini-Strambi L, Ferri R. Targeting orexin receptors for the treatment of insomnia: from physiological mechanisms to current clinical evidence and recommendations. Nat Sci Sleep. 2023;15:17–38. doi:10.2147/NSS.S201994
  • Moline M, Thein S, Bsharat M, et al. Safety and efficacy of lemborexant in patients with irregular sleep-wake rhythm disorder and Alzheimer’s disease dementia: results from a Phase 2 randomized clinical trial. J Prev Alzheimers Dis. 2021;8:7–18. doi:10.14283/jpad.2020.69
  • Kawai K, Iwamoto K, Miyata S, et al. A study of factors causing sleep state misperception in patients with depression. Nat Sci Sleep. 2022;14:1273–1283. doi:10.2147/NSS.S366774
  • Wang Y, Loparo KA, Kelly MR, et al. Evaluation of an automated single-channel sleep staging algorithm. Nat Sci Sleep. 2015;7:101–111. doi:10.2147/NSS.S77888
  • Miyata S, Iwamoto K, Banno M, et al. Performance of an ambulatory electroencephalogram sleep monitor in patients with psychiatric disorders. J Sleep Res. 2021;30:e13273.
  • Lunsford-Avery JR, Keller C, Kollins SH, Krystal AD, Jackson L, Engelhard MM. Feasibility and acceptability of wearable sleep electroencephalogram device use in adolescents: observational study. JMIR Mhealth Uhealth. 2020;8(10):e20590. doi:10.2196/20590
  • Yap Y, Yan Chi Tung N, Collins J, Phillips A, Bei B, Wiley JF. Daily relations between stress and electroencephalography-assessed sleep: a 15-day intensive longitudinal design with ecological momentary assessments. Ann Behav Med. 2022;56(11):1144–1156. doi:10.1093/abm/kaac017
  • Brandt R, Park M, Wroblewski K, et al. Sleep quality and glycaemic variability in a real-life setting in adults with type 1 diabetes. Diabetologia. 2021;64(10):2159–2169. doi:10.1007/s00125-021-05500-9
  • Okada I, Iwamoto K, Miyata S, et al. FLUID study: study protocol for an open-label, single-centre pilot study to investigate the efFect of Lemborexant on sleep management in Japanese subjects aged 50 years and older with insomnia disorder. BMJ open. 2021;11(11):e054885. doi:10.1136/bmjopen-2021-054885
  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. doi:10.1016/0165-1781(89)90047-4
  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540–545. doi:10.1093/sleep/14.6.540
  • Cloninger CR, Przybeck TR, Svrakic DM, Wetzel RD. The Temperament and Character Inventory (TCI): A Guide to Its Development and Use. St Louis: Center for Psychobiology of Personality; 1994.
  • Beck AT, Steer RA, Ball R, Ranieri W. Comparison of beck depression inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996;67(3):588–597. doi:10.1207/s15327752jpa6703_13
  • 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. doi:10.5664/jcsm.6800
  • Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet. 2002;359(9307):696–700. doi:10.1016/S0140-6736(02)07816-9
  • Katz M. Study Design and Statistical Analysis: A Practical Guide for Clinicians. Cambridge: Cambridge University Press; 2006.
  • Molzof HE, Emert SE, Tutek J, et al. Intraindividual sleep variability and its association with insomnia identity and poor sleep. Sleep Med. 2018;52:58–66. doi:10.1016/j.sleep.2018.08.014
  • Inoue Y, Nishida M, Kubota N, et al. Comparison of the treatment effectiveness between lemborexant and zolpidem tartrate extended release for insomnia disorder subtypes defined based on polysomnographic findings. J Clin Sleep Med. 2023;19(3):519–528. doi:10.5664/jcsm.10378
  • Inoue Y, Watanabe T, Takashima S, et al. Efficacy and safety of lemborexant in adults with insomnia: comparing Japanese and non-Japanese subgroups from the global, phase 3, randomized, double-blind, placebo-controlled SUNRISE 2 study. J Clin Sleep Med. 2021;17(5):1067–1074. doi:10.5664/jcsm.9148
  • Cudney LE, Frey BN, McCabe RE, et al. Investigating the relationship between objective measures of sleep and self-report sleep quality in healthy adults: a review. J Clin Sleep Med. 2022;18(3):927–936. doi:10.5664/jcsm.9708
  • Rezaie L, Fobian AD, McCall WV, et al. Paradoxical insomnia and subjective-objective sleep discrepancy: a review. Sleep Med Rev. 2018;40:196–202. doi:10.1016/j.smrv.2018.01.002
  • Xu H, Zhang C, Qian Y, et al. Efficacy of melatonin for sleep disturbance in middle-aged primary insomnia: a double-blind, randomised clinical trial. Sleep Med. 2020;76:113–119. doi:10.1016/j.sleep.2020.10.018
  • Sadler P, McLaren S, Klein B, et al. Cognitive behavior therapy for older adults with insomnia and depression: a randomized controlled trial in community mental health services. Sleep. 2018;41(8):zsy104. doi:10.1093/sleep/zsy104
  • Guthrie KA, Larson JC, Ensrud KE, et al. Effects of pharmacologic and nonpharmacologic interventions on insomnia symptoms and self-reported sleep quality in women with hot flashes: a pooled analysis of individual participant data from four MsFLASH trials. Sleep. 2018;41(1):zsx190. doi:10.1093/sleep/zsx190