Side Effects of doxepin (insomnia): A Synthesis of Findings from 10 Studies

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Original Abstract of the Article

Main Research Findings

Doxepin is a tricyclic compound that has been widely used for the treatment of depressive and anxiety disorders for approximately thirty years. 4 It was noted early to have sedative effects and assist with the improvement of disrupted sleep patterns, but in higher antidepressant doses it was also noted to have significant anticholinergic and antinoradrenergic properties. 4 These properties led to significant dose-limiting side effects, which at times precluded its effective use. Recently, doxepin has seen renewed interest in low doses as an H1 specific antagonist in sleep disorders. 3

Doxepin, a sedating tricyclic drug, at 3 mg and 6 mg doses was recently approved by the U.S. food and drug administration (FDA) for the treatment of insomnia. 3 This systematic review found that low-dose doxepin had a small to medium effect size against placebo for sleep maintenance and sleep duration but not for sleep initiation at both immediate and short-term posttreatment. 3 There was no significant next-day residual effect with low-dose doxepin. 3 Headache and somnolence were the most common side effects. 3

We concluded that low-dose doxepin for 1-2 nights appeared to be safe and effective in improving sleep. 3 However, a clear conclusion on its short-term benefits and risks as well as withdrawal effects was not possible due to the small number of studies. 3

Reasons for Side Effects

The side effects of doxepin are due to its pharmacological action. Doxepin is an H1 receptor antagonist, so it can cause side effects such as drowsiness and headache. 4 Doxepin also has anticholinergic and antinoradrenergic properties, so it can cause side effects such as dry mouth, constipation, and difficulty urinating. 4

Common Side Effects

Drowsiness

Drowsiness is the most common side effect of low-dose doxepin. 3 This side effect is due to the antihistamine action of doxepin. 4

Headache

Headache is another side effect that has been reported with low-dose doxepin. 3 This side effect may also be due to the antihistamine action of doxepin. 4

Dry Mouth

Doxepin can cause side effects such as dry mouth due to its anticholinergic action. 4

Constipation

The anticholinergic action of doxepin can also cause side effects such as constipation. 4

Difficulty Urinating

Doxepin can also cause side effects such as difficulty urinating. 4

Side Effect Management

Drowsiness

To reduce drowsiness, it is recommended to take doxepin at bedtime. 3 If drowsiness is severe, consult a doctor. 3

Headache

If you have a headache, consult your doctor. 3

Dry Mouth

If you have dry mouth, drink plenty of fluids. 4

Constipation

If you have constipation, eat a diet high in fiber and drink plenty of fluids. 4 Consult your doctor if necessary. 4

Difficulty Urinating

If you have difficulty urinating, consult your doctor. 4

Comparison between Studies

Commonalities in Studies

Multiple studies have shown that low-dose doxepin may be effective in the treatment of insomnia. 7 3 5

Differences in Studies

The dosage of doxepin that was effective and the effect on sleep varied depending on the study. 7 3 5 Some studies reported different side effects of doxepin. 7 3 5

Application to Daily Life

While low-dose doxepin may be effective in treating insomnia, it is important to consider the risk of side effects. 3 Side effects such as drowsiness and headache can be reduced by taking doxepin at bedtime. 3 Doxepin can also interact with other medications, so it is important to consult your doctor before taking it. 3

Limitations of Current Research

Research on doxepin is still insufficient. 3 Further research is needed, especially on the safety and efficacy of long-term use. 3

Future Research Directions

Research is needed to assess the safety and efficacy of long-term use of doxepin. 3 Further research is also needed on the optimal dosage of doxepin and its interactions with other medications. 3

Conclusion

While low-dose doxepin may be effective in the treatment of insomnia, it is important to consider the risk of side effects. 3 Always consult your doctor before taking doxepin. 3

Literature analysis of 10 papers
Positive Content
10
Neutral Content
0
Negative Content
0
Article Type
3
1
1
6
10
1.

Doxepin in children and adolescents with symptoms of insomnia: a single-center experience.

Author: ShahYash D, StringelVirginia, PavkovicIvan, KothareSanjeev V

Pediatric insomnia treatment

This study evaluated the efficacy and tolerability of doxepin in pediatric patients with insomnia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

2.

Treatment of insomnia with tricyclic antidepressants: a meta-analysis of polysomnographic randomized controlled trials.

Author: LiuYang, XuXiaomin, DongMeixue, JiaShiyu, WeiYoudong

Improved sleep
Somnolence

Tricyclic antidepressants (TCAs) were found to be an effective treatment for insomnia, as they were found to improve sleep outcome measures, with the notable exception of an 82% increase in somnolence.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Doxepin for insomnia: a systematic review of randomized placebo-controlled trials.

Author: YeungWing-Fai, ChungKa-Fai, YungKam-Ping, NgTommy Ho-Yee

Insomnia treatment
Headache
Somnolence

Doxepin is a sedating medication that has been approved for the treatment of insomnia. This review found that low doses of doxepin (1-6 mg/day) were effective at improving sleep maintenance and sleep duration but not sleep initiation. The review also found that doxepin was well-tolerated, with the most common side effects being headache and drowsiness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

4.

Low-dose doxepin for the treatment of insomnia: emerging data.

Author: GoforthHarold W

Sleep disorders
Anticholinergic effects
Antinoradrenergic effects

This article discusses the use of doxepin, a tricyclic compound, for the treatment of depressive and anxiety disorders. The article focuses on its sedative effects and its renewed interest as an H1 specific antagonist in sleep disorders.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

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.

Author: ScharfMartin, RogowskiRoberta, HullSteven, CohnMartin, MaylebenDavid, FeldmanNeil, EreshefskyLarry, LankfordAlan, RothThomas

Improved sleep

Doxepin at doses of 1 mg, 3 mg, and 6 mg was well tolerated and produced significant improvements in sleep maintenance and duration in elderly adults with primary insomnia. The highest dose, 6 mg, was most effective in improving sleep onset.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

The sleep-improving effects of doxepin are paralleled by a normalized plasma cortisol secretion in primary insomnia. A placebo-controlled, double-blind, randomized, cross-over study followed by an open treatment over 3 weeks.

Author: RodenbeckA, CohrsS, JordanW, HuetherG, RütherE, HajakG

Insomnia treatment

This study explores the potential link between sleep and cortisol secretion in the mode of action of sedating antidepressants used for treating insomnia.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

7.

Doxepin in the treatment of primary insomnia: a placebo-controlled, double-blind, polysomnographic study.

Author: HajakG, RodenbeckA, VoderholzerU, RiemannD, CohrsS, HohagenF, BergerM, RütherE

Antidepressant tolerability
Insomnia treatment

This study examines the effectiveness and tolerability of low-dose sedating antidepressants for treating insomnia. It is the first study to demonstrate objective efficacy and tolerability of this treatment approach in a randomized, double-blind, placebo-controlled trial in patients with primary insomnia.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Review of the results from clinical studies on the efficacy, safety and tolerability of mirtazapine for the treatment of patients with major depression.

Author: FawcettJ, BarkinR L

Anxiolytic
Effective antidepressant
Improved tolerability
Rapid onset of action
Sleep-improving
Hyperphagia
Somnolence
Weight gain

Mirtazapine is an antidepressant that has a unique tolerability profile. It's an effective and well-tolerated option for treating major depression, especially in patients with anxiety or insomnia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Fluoxetine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in depressive illness.

Author: BenfieldP, HeelR C, LewisS P

Fewer anticholinergic effects
Improved depression
Low relapse rate
Insomnia
Nausea
Nervousness

Fluoxetine, a selective serotonin reuptake inhibitor, has demonstrated comparable efficacy to tricyclic antidepressants in treating unipolar depression. It is associated with fewer anticholinergic side effects and a favorable safety profile, making it a potential alternative for patients with depression.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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