Drug Treatment of Primary Insomnia: A Meta-Analysis of Polysomnographic Randomized Controlled Trials

Winkler, Alexander W.; Auer, Charlotte J.; Doering, Bettina K.; Rief, Winfried

doi:10.1007/s40263-014-0198-7

Cited by 116 publications

(59 citation statements)

References 63 publications

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“…38 In placebo-controlled trials, persistent self-reported efficacy for insomnia was shown for nightly use of eszopiclone for 6 months 39 and for intermittent use of extended-release zolpidem over a period of 6 months. 40 A randomized, controlled trial involving patients with chronic insomnia showed that as compared with CBT alone, the combination of CBT and a benzodiazepine-receptor agonist was associated with a larger increase in total sleep time at 6 weeks as well as a higher remission rate at 6 months.…”

Section: Benzodiazepine-receptor Agonistsmentioning

confidence: 99%

Insomnia Disorder

Winkelman

2015

N Engl J Med

193

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A 77-year-old overweight woman with hypertension and arthritis reports that she has had trouble sleeping for "as long as I can remember." She has taken hypnotic medications nightly for almost 50 years; her medication was recently switched from lorazepam (1 mg), which had been successful, to trazodone (25 mg) by her primary care physician, who was concerned about her use of the former. She spends 9 hours in bed, from 11 p.m. to 8 a.m. She has only occasional difficulty falling asleep, but she awakens two to three times per night to urinate and lies in bed for over an hour at those times, "just worrying." How should her case be managed?

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Section: Benzodiazepine-receptor Agonistsmentioning

confidence: 99%

Insomnia Disorder

Winkelman

2015

N Engl J Med

193

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“…[29] support the efficacy of BZD in treating insomnia. In addition significant adverse effects like cognitive and psychomotor impairment, next-day hangover, rebound insomnia, anterograde amnesia and dependence have been documented turning controversial the use of BZD for treatment of insomnia in the elderly.…”

Section: Bzd and Related Drugs In Insomniamentioning

confidence: 68%

Assessing the efficacy of melatonin to curtail benzodiazepine/Z drug abuse

Cardinali

Golombék

Rosenstein

et al. 2016

Pharmacological Research

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The abuse of benzodiazepine (BZP) and Z drugs has become, due to the tolerance and dependence they produce, a serious public health problem. Thirty years ago, we demonstrated in experimental animals the interaction of melatonin with central BZD receptors, and in 1997 we published the first series of elderly patients who reduced BZP consumption after melatonin treatment. Almost every single neuron in the hypothalamic suprachiasmatic nuclei (SCN), the central pacemaker of the circadian system, contains γ-aminobutyric acid (GABA) and many results in animals point out to a melatonin interaction with GABA-containing neurons. In addition, central-type BZD antagonism, that obliterates GABAA receptor function, blunted most behavioral effects of melatonin including sleep. Melatonin is involved in the regulation of human sleep. This is supported by the temporal relationship between the rise of plasma melatonin levels and sleep propensity as well as by the sleep-promoting effects of exogenously administered melatonin. Both meta-analyses and consensus agreements give support to the therapeutic use of melatonin in sleep disorders. This action is attributed to MT1 and MT2 melatoninergic receptors localized in the SCN, as well as in other brain areas. This review discusses available data on the efficacy of melatonin to curtail chronic BZD/Z drug use in insomnia patients. A major advantage is that melatonin has a very safe profile, it is usually remarkably well tolerated and, in some studies, it has been administered to patients at very large doses and for long periods of time, without any potentiality of abuse. Further studies on this application of melatonin are warranted.

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“…[26][27] However in meta-analysis of polysomnographic randomized control trials by Winker A et al, 2014 have reported higher effect for benzodiazepine receptor agonist and classical benzodiazepines in comparison to antidepressants (Including low dose Doxepin) but they concluded that additional consideration of side effects profile can lead to alternative treatment decisions. 28 Both the drugs in the study were safe and tolerable. No adverse effects were reported.…”

Section: Discussionmentioning

confidence: 87%

A Double Blind, Randomized, Parallel Group, Prospective, Clinical Study for Evaluation of Efficacy and Safety of Low Dose Doxepin in Comparision With Zopiclone in Adult and Elderly Patients With Primary Insomnia

Rastogi¹,

Rastogi²

2015

jemds

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BACKGROUND:Insomnia is underappreciated public health issue. In recent years, insomnia treatment has advanced beyond the routine use of benzodiazepines. AIMS: To compare the efficacy and safety of low dose Doxepin with Zopiclone in patients with primary insomnia. SETTINGS AND DESIGN: A double blind, randomized parallel group, prospective study of low dose Doxepin (n=20) and Zopiclone (n=15) in patients with primary insomnia. METHODS & MATERIAL:Patients fulfilling the selection criteria were enrolled. Enrolled patients were randomized to 2 groups-of low dose Doxepin(3mg) and Zopiclone (3.75mg). Patients were provided with sleep diaries to record sleep parameters, change in alertness and mood, sleepiness scale score and other adverse events were recorded. STATISTICAL ANALYSIS: Student 't' test. RESULTS: Both the groups show significant reduction the time of wakening after sleep onset, with improvement in both total sleep time & sleep efficiency. Both the drugs were well tolerated and percentage change in mood and alertness was comparable. CONCLUSION: Low dose Doxepin was found to be as effective and safe as Zopiclone in patients of primary insomnia. HOW TO CITE THIS ARTICLE:

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Drug Treatment of Primary Insomnia: A Meta-Analysis of Polysomnographic Randomized Controlled Trials

Cited by 116 publications

References 63 publications

Insomnia Disorder

Insomnia Disorder

Assessing the efficacy of melatonin to curtail benzodiazepine/Z drug abuse

A Double Blind, Randomized, Parallel Group, Prospective, Clinical Study for Evaluation of Efficacy and Safety of Low Dose Doxepin in Comparision With Zopiclone in Adult and Elderly Patients With Primary Insomnia

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