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Doxepin in the Treatment of Primary Insomnia: A Placebo-Controlled, Double-Blind, Polysomnographic Study
Abstract
Background Over recent years, the use of antidepressants for the symptomatic treatment of insomnia has grown substantially, but controlled studies are still lacking. Our study is the first investigation to prove objective efficacy and tolerability of low doses of a sedating antidepressant in a randomized, double-blind, and placebo-controlled manner in patients with primary insomnia. Method Forty-seven drug-free patients meeting DSM-IV criteria for primary insomnia (mean +/- SD duration of complaints = 11.2+/-9.7 years) received either 25-50 mg of the tricyclic antidepressant doxepin or placebo for 4 weeks followed by 2 weeks of placebo withdrawal. Sleep was measured by polysomnography at baseline and the first night of application, at 4 weeks of treatment and the first to third night of withdrawal, and after 2 weeks of withdrawal. Results In the doxepin-treated patients who completed the study (N = 20, 47.6+/-11.3), medication significantly increased sleep efficiency after acute (night 1, p Conclusion The results support the effectiveness of low doses of doxepin to improve sleep and working ability in chronic primary insomniacs, although subjective effects were light to moderate, and in some patients, rebound insomnia and specific side effects have to be considered.
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“Evidence for their efficacy when used alone is relatively weak 38-42 and no specific agent within this group is recommended as preferable to the others in this group.”
From Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults (2008) · cites this paper as [38]
In the citing paper
“Sleep efficiency and sleep quality were significantly improved for insomnia patients taking doxepin (25-50mg), compared to placebo (Hajak et al., 2001), while doxepin (25mg) was associated with significantly increased total sleep time, and significantly reduced sleep latency and length of nocturnal awakenings, compared to placebo with insomnia patients and healthy volunteers (Hajak et al., 1996).”
From Antidepressants and their effect on sleep (2005) · cites this paper as Hajak et al., 2001
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“Controlled trials have demonstrated an effect of doxepin in insomnia at low dose (25mg) for 4weeks with rebound insomnia (Hajak et al., 2001), and very low ‘microdose’ studies using 1, 2 or 6mg for two nights in adult (Roth et al.”
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“Although in some patients rebound insomnia and specific side effects of doxepin have to be considered (Hajak et al. 2001a), the results give a further rationale for the use of sedating antidepressants in the treatment of sleep complaints.”
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“This absence of the typical antihistamine side effects replicates the safety findings from previous clinical trials assessing DXP 66 mg in insomnia patients [14–17]; additionally, these previous sleep laboratory trials did not report evidence of REM suppression [14–17], a finding seen in previous trials assessing dose…”
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Self-citationDSC kinetic study of the incompatibility of doxepin with dextrose
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Nichterholsamer Schlaf und Insomnie
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Self-citationThe guidelines for ‘non-restorative sleep’: Relevance for the diagnosis and therapy of insomnia
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Self-citationClinical Sleep–Wake Disorders II: Focus on Insomnia and Circadian Rhythm Sleep Disorders
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Self-citationDoxepin in children and adolescents with symptoms of insomnia: A single-center experience
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“In another randomized controlled trial, a single dose of doxepin 25 or 50mg did improve associated sleep difficulties in patients with chronic primary insomnia.(28) In our study, we observed that there was improvement in terms of both sleep initiation and maintenance.”
Die Bedeutung des Schlafs für gesunde Alkoholkonsumenten und alkoholabhängige Patienten
Gann, P. H., van Calker, D., Feige, B., & Riemann, D. (2004) · Der Nervenarzt · doi:10.1007/s00115-003-1637-8 · Cited by 16
Self-citationThe condition of insomnia: Etiopathogenetic considerations and their impact on treatment practices
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“This is particularly the case for trazodone (Mendelson et al., 2004), doxepin (Hajak et al., 2001; Rodenbeck et al., 2003) and mirtazapine (Barkin, Chor, Braun & Schwer, 1999), although their efficacy, dose-response, tolerance, and benefit/ harm ratio have not been established in insomniacs…”
Nefazodone in primary insomnia: an open pilot study
Wiegand, M. H., Galanakis, P., & Schreiner, R. (2004) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2004.05.042 · Cited by 13
“For two compounds only, there is evidence from randomized, placebo-controlled trials proving their efficacy in primary insomnia: doxepin (Hajak et al., 2001) confirming data from a preceding open study (Hajak et al., 1996), and trimipramine (Riemann et al., 2002) confirming preceding single-blind…”
ResultPharmacologic Treatment of Primary Insomnia
Walsh, J. K., Roehrs, T., & Roth, T. G. (2005) · Elsevier eBooks · doi:10.1016/b0-72-160797-7/50070-7 · Cited by 52
Clinical Pharmacology of Other Drugs Used as Hypnotics
Buysse, D. J., & Tyagi, S. (2016) · Elsevier eBooks · doi:10.1016/b978-0-323-24288-2.00042-8 · Cited by 34
Alcohol, toxins, and medications as a cause of sleep dysfunction
Conroy, D. A., & Brower, K. J. (2010) · Handbook of clinical neurology · doi:10.1016/b978-0-444-52006-7.00038-1 · Cited by 14
Woo, J., Ha, T.-W., Kang, J., Hong, J., & Oh, K. (2016) · Korean Journal of Physiology and Pharmacology · doi:10.4196/kjpp.2017.21.1.27 · Cited by 11
“We considered that DCA would be inhibitory in the CNS. DCA also prolonged sleeping time, and decreased the sleep latency by pentobarbital (42 mg/kg), in a dose- Fig.”
InfluentialCrescenzo, F. D., Foti, F., Ciabattini, M., Giovane, C. D., Watanabe, N., Schepisi, M. S., Quested, D. J., Cipriani, A., Barbui, C., & Amato, L. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012364 · Cited by 13
Wu, J.-F., Chang, F., & Zu, H.-B. (2015) · Experimental and Therapeutic Medicine · doi:10.3892/etm.2015.2686 · Cited by 11
“Doxepin has marked inhibitory effects on neurotransmitter receptors, including the histamine, serotonin, α 1 adrenergic and muscarinic acetylcholine receptors (12), and has been shown to strongly promote the initiation and maintenance of sleep and to improve sleep quality (11,12).”
Subjektive Parameter des Schlafs bei Patienten mit primärer Alkoholabhängigkeit
Gann, H., Landbrecht, M., Feige, B., Hohagen, F., & Riemann, D. (2001) · doi:10.1046/j.1439-054x.2001.01151.x · Cited by 10
Self-citationWang, F., He, J., Zhou, Y., Ye, L., Li, B., Ma, Z., Chen, C., Zhang, R., Lin, Z., Tang, J., et al. (2023) · Frontiers in Pharmacology · doi:10.3389/fphar.2023.1226014 · Cited by 10
Owen, N. E., Barker, R. A., & Voysey, Z. J. (2023) · Journal of Huntington s Disease · doi:10.3233/jhd-230567 · Cited by 13
“Doxepin has also been shown to increase total sleep time and overall sleep efficiency in young, middle-aged, and elderly primary insomnia patients [76-78].”
BackgroundLing, S., & Swaab, D. (2021) · Current Neuropharmacology · doi:10.2174/1570159x19666210909144930 · Cited by 9
“Several other studies showed similar improvement in sleep maintenance and sleep duration with doxepin compared to placebo [61-65].”
Diagnosis and treatment of chronic insomnia
Saddichha, S. (2010) · Annals of Indian Academy of Neurology · doi:10.4103/0972-2327.64628 · Cited by 137
“Evidence for their effi cacy when used alone is relatively weak and hence no specifi c agent within this group is recommended as preferable to the others in this group.[58-61]”
Efficacy and Safety of Sleep-Promoting Agents
Roth, T., & Roehrs, T. (2008) · Sleep Medicine Clinics · doi:10.1016/j.jsmc.2008.03.001 · Cited by 9
Metadata
- Authors
- Hajak, G., Rodenbeck, A., Voderholzer, U., Riemann, D., Cohrs, S., Hohagen, F., Berger, M., & Ruther, E.
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2001-06-15
- Volume
- 62
- Issue
- 6
- Pages
- 453-463
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2060370838
- Cited by
- 199
- References
- 0
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 2 · 2023: 6 · 2022: 6 · 2021: 5 · 2020: 4 · 2019: 9 · 2018: 3 · 2017: 9 · 2016: 8 · 2015: 13 · 2014: 11 · 2013: 11 · 2012: 8
- FWCI
- 9.46
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- University of Regensburg Publication Server (University of Regensburg) (acceptedVersion)
- FreiDok plus (Universitätsbibliothek Freiburg) (submittedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Health Sciences › Medicine › Physiology (medical) › Obstructive Sleep Apnea Research
- Keywords
- doxepin, primary insomnia, tricyclic antidepressants, sedating antidepressants, sleep efficiency, rebound insomnia, sleep quality, work ability, drug tolerability, chronic insomnia
- MeSH terms
- Antidepressive Agents, Tricyclic, Chronic Disease, Dose-Response Relationship, Drug, Double-Blind Method, Doxepin, Drug Administration Schedule, Female, Health Status, Humans, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Patient Dropouts, Placebos, Psychiatric Status Rating Scales, Severity of Illness Index, Sleep, Treatment Outcome, Polysomnography
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