Off-label low dose amitriptyline for insomnia disorder: Patient-reported outcomes.
insomnia disorder
low dose amitriptyline
off-label treatment
patient-reported outcomes
sleep maintenance
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
revised:
15
09
2022
received:
23
06
2022
accepted:
26
10
2022
pubmed:
31
10
2022
medline:
25
3
2023
entrez:
30
10
2022
Statut:
ppublish
Résumé
Low dose amitriptyline is prescribed off-label to improve sleep maintenance in patients with insomnia disorder. Data on treatment outcomes are limited. We aimed to assess patient-reported treatment effect and side effects of low dose amitriptyline for insomnia in routine care data. Cross-sectional study: Seven hundred fifty-two consecutive patients with insomnia disorder having sleep maintenance problems were treated in an outpatient sleep clinic with low dose amitriptyline (10-20 mg based on self-titration). Treatment was intended to improve sleep maintenance. Before the planned follow-up consultation (approximately 6 weeks after start treatment) patients completed an online treatment evaluation questionnaire. Treatment (dose, adherence), sleep, fatigue, satisfaction and side effects were assessed by multiple-choice questions with room for free-text elaboration. 53.7% of the patients reported to use amitriptyline up to 10 mg/day, 42.9% used a self-increased dose of mostly 20 mg/day, while 3.5% had discontinued treatment. 73.9% of the total study population reported improvement of sleep maintenance, 31.3% improved sleep onset, 35.2% improved daytime fatigue, and 45.8% reported to be (very) satisfied with treatment results. 66.1% reported at least one side effect. The reported side effects were generally the already known side effects of amitriptyline. These patient-reported outcomes support the clinical observations that low dose amitriptyline improves sleep maintenance on the short term and that it is generally well tolerated. This further justifies randomized controlled trials in patients with insomnia disorder and sleep maintenance problems to assess the effectiveness and safety of low dose amitriptyline on the short and long term.
Substances chimiques
Amitriptyline
1806D8D52K
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
435-445Informations de copyright
© 2022 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
Références
American Psychiatric Association, ed. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. American Psychiatric Association; 2013.
Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111. doi:10.1053/smrv.2002.0186
Daley M, Morin CM, LeBlanc M, Grégoire JP, Savard J, Baillargeon L. Insomnia and its relationship to health-care utilization, work absenteeism, productivity and accidents. Sleep Med. 2009;10(4):427-438. doi:10.1016/j.sleep.2008.04.005
Gustavsson A, Svensson M, Jacobi F, et al. Cost of disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011;21(10):718-779. doi:10.1016/j.euroneuro.2011.08.008
Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4(5):487-504.
Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. 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. doi:10.7326/m15-2175
Ree M, Junge M, Cunnington D. Australasian Sleep Association position statement regarding the use of psychological/behavioral treatments in the management of insomnia in adults. Sleep Med. 2017;36(Suppl 1):S43-S47. doi:10.1016/j.sleep.2017.03.017
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
Galbiati A, Sforza M, Fasiello E, Castronovo V, Ferini-Strambi L. Impact of phenotypic heterogeneity of insomnia on the Patients' response to cognitive-behavioral therapy for insomnia: current perspectives. Nat Sci Sleep. 2019;11:367-376. doi:10.2147/nss.S198812
Cortoos A, Verstraeten E, Cluydts R. Neurophysiological aspects of primary insomnia: implications for its treatment. Sleep Med Rev. 2006;10(4):255-266. doi:10.1016/j.smrv.2006.01.002
Glass J, Lanctôt KL, Herrmann N, Sproule BA, Busto UE. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ (Clin Res Ed). 2005;331(7526):1169. doi:10.1136/bmj.38623.768588.47
Everitt H, McDermott L, Leydon G, Yules H, Baldwin D, Little P. GPs' management strategies for patients with insomnia: a survey and qualitative interview study. Br J General Pract. 2014;64(619):e112-e119. doi:10.3399/bjgp14X677176
Wong J, Motulsky A, Abrahamowicz M, Eguale T, Buckeridge DL, Tamblyn R. Off-label indications for antidepressants in primary care: descriptive study of prescriptions from an indication based electronic prescribing system. BMJ (Clin Res Ed). 2017;356:j603. doi:10.1136/bmj.j603
Lai LL, Tan MH, Lai YC. Prevalence and factors associated with off-label antidepressant prescriptions for insomnia. Drug Healthc Patient Safety. 2011;3:27-36. doi:10.2147/dhps.S21079
Wilson S, Nutt D. Management of insomnia: treatments and mechanismsi. Br J Psychiatry. 2007;191:195-197. doi:10.1192/bjp.bp.107.036301
Saarto T, Wiffen PJ. Antidepressants for neuropathic pain: a Cochrane review. J Neurol Neurosurg Psychiatry. 2010;81(12):1372-1373. doi:10.1136/jnnp.2008.144964
ElectronicMedicinesCompendium. Amitriptyline 10 mg Tablet BP-Summary of Product Characteristics (SPC)-(eMC). Updated 26-03-2021. Accessed June 03, 2021, https://www.medicines.org.uk/emc/product/5698/smpc#DOCREVISION
Krystal AD, Richelson E, Roth T. Review of the histamine system and the clinical effects of H1 antagonists: basis for a new model for understanding the effects of insomnia medications. Sleep Med Rev. 2013;17(4):263-272. doi:10.1016/j.smrv.2012.08.001
Mayers AG, Baldwin DS. Antidepressants and their effect on sleep. Hum Psychopharmacol. 2005;20(8):533-559. doi:10.1002/hup.726
Everitt H, Baldwin DS, Stuart B, et al. Antidepressants for insomnia in adults. Cochrane Database Syst Rev. 2018;5(5):Cd010753. doi:10.1002/14651858.CD010753.pub2
Association AP, ed. Diagnostic and Statistical Manual of Mental Disorders: DSM-IV-TR. 4th ed. Association AP; 2000 (text revision ed.).
Ivgy-May N, Roth T, Ruwe F, Walsh J. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a 2-week randomized outpatient trial. Sleep Med. 2015;16(7):831-837. doi:10.1016/j.sleep.2015.03.005
Savarese M, Carnicelli M, Cardinali V, Mogavero MP, Federico F. Subjective hypnotic efficacy of trazodone and mirtazapine in patients with chronic insomnia: a retrospective, comparative study. Arch Ital Biol. 2015;153(2-3):231-238. doi:10.12871/0003982920152348
Krystal AD, Durrence HH, Scharf M, et al. Efficacy and safety of doxepin 1 mg and 3 mg in a 12-week sleep laboratory and outpatient trial of elderly subjects with chronic primary insomnia. Sleep. 2010;33(11):1553-1561. doi:10.1093/sleep/33.11.1553
Lankford A, Rogowski R, Essink B, Ludington E, Heith Durrence H, Roth T. Efficacy and safety of doxepin 6 mg in a four-week outpatient trial of elderly adults with chronic primary insomnia. Sleep Med. 2012;13(2):133-138. doi:10.1016/j.sleep.2011.09.006
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. doi:10.5665/sleep.1294
Scharf M, Rogowski R, Hull S, et al. Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in elderly patients with primary insomnia: a randomized, double-blind, placebo-controlled crossover study. J Clin Psychiatry. 2008;69(10):1557-1564. doi:10.4088/jcp.v69n1005
Food and Drug Administration. Methods to identify what is important to patients & select, develop or modify fit-for-purpose clinical outcomes assessments. Meeting material Attachment to Discussion Document for Patient-Focused Drug 2 Development Public Workshop on Guidance 3 Workshop Date 15/16-10-2018. 2019. Accessed June 03, 2021, https://www.fda.gov/drugs/news-events-human-drugs/patient-focused-drug-development-guidance-methods-identify-what-important-patients-and-select.