Effectiveness and Safety of Doxepin for Primary Insomnia: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

YUAN Jinqiu ^1,2 , YANG Kehu ^1,2 ,  LIU Yali ¹ , YANG Shengping ^1,2

1. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China2. The First Clinical Medical College of Lanzhou University, Lanzhou 730000, China;

Corresponding author：

LIU Yali, Email: lyl_201006@126.com

Keywords：

Doxepin; Insomnia; Systematic review; Randomized controued trial; Cross trial

DOI：

10.7507/1672-2531.20100590

Video：

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Objective 　To evaluate the effectiveness and safety of doxepin in the treatment of primary insomnia.
Methods 　We searched The Cochrane Library (Issue 4, 2009), PubMed (1966 to December 2009), EMbase (1974 to December 2009), ISI (1961 to December 2009), CNKI (1979 to December 2009), VIP (1989 to December 2008), CBM (1978 to December 2009), and WANFANG Data (1998 to December 2009). We also searched the correlated grey literature and conference literature for complement. Data were extracted, methodologically evaluated, and cross-checked by two reviewers independently. RevMan 5.0 was used for statistical analysis.
Results 　One randomized controlled trial and three cross trials involving 171 patients were included. The results of meta-analyses showed that total sleep time (TST), wake time during sleep (WTDS), wake time after sleep (WTAS), and sleep efficiency (SE) were improved by low and medium dosage of doxepin (1-25 mg) with statistically significant difference compared with placebo. On the contrary, most indicators of sleep quality had no statistically significant difference between high dose doxepin (50 mg) and placebo. While the sleeping structural indicators of rapid eye movement sleep (REM), rapid-eyemovement latency (REM-L), and sleep stage II (St.II) were changed by high and medium dosage of doxepin (25-50 mg) with statistically significant difference.
Conclusions 　Low and medium dosage of doxepin (1-25 mg) is effective in improvement of the sleep quality in patients with primary insomnia, but it is necessary to concern the side effects and the effects on sleep structure when treating primary insomnia with medium dosage of doxepin (25 mg). High dosage of doxepin (50 mg) is not recommended to treat primary insomnia. However, this conclusion still needs clinical trials to be further validated.

Citation： YUAN Jinqiu,YANG Kehu,LIU Yali,YANG Shengping. Effectiveness and Safety of Doxepin for Primary Insomnia: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2010, 10(11): 1325-1330. doi: 10.7507/1672-2531.20100590 Copy

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1. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Medicine Reviews, 2002, 6(2): 97-111.
2. Daley M, Morin CM, LeBlanc M. The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers. Sleep, 2009, 32(1): 55-64.
3. Hajak G, Rodenbeck A, Voderholzer U. Doxepin in the treatment of primary insomnia: a placebo-controlled, double-blind, polysomnographic study. J Clin Psychiatry, 2001, 62(6): 453-463.
4. Rodenbeck A, Cohrs S, Jordan W. The sleep-improving effects of doxepin are paralleled by a normalized plasma cortisol secretion in primary insomnia. Psychopharmacology (Berl), 2003, 170(4): 423-428.
5. Roth T, Rogowski R, Hull S. Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in adults with primary insomnia. Sleep, 2007, 30(11): 1555-1561.
6. 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.
7. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www. cochrane-handbook.org.
8. Mansbach R. In vitro pharmacological profile of doxepin, a sleep-promoting histamine H1 antagonist. European. Neuropsychopharmacology, 2008, 18(Suppl): 4.
9. 宿长军, 刘煜, 李柱一. 黛力新与多塞平联合治疗原发性失眠.第四军医大学学报, 2005, 26(5): 2010-2012.
10. 季红宁, 赵慧丽, 张海燕. 神衰康合用多虑平治疗神经症性失眠临床观察. 河北医药, 2001, 23(3): 216-217.
11. 陈伟良. 多虑平合并心理治疗对失眠症的疗效观察.现代医药卫生, 2002, 18(6): 465-466.
12. 王桂清, 赵克虎. 扩血管药联合多虑平治疗中老年人慢性失眠52例. 实用医药杂志, 2006, 23(7): 863.

Chinese Journal of Evidence-Based Medicine

Effectiveness and Safety of Doxepin for Primary Insomnia: A Systematic Review

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