Subjective hypnotic efficacy of trazodone and zolpidem in DSMIII-R primary insomnia

Walsh, James K.; Erman, Milton K.; Erwin, C. W.; Jamieson, Andrew O.; Mahowald, Mark W.; Regestein, Quentin R.; Scharf, Martin B.; Tigel, Phillip D.; Vogel, Gerald W.; Ware, J. Catesby

doi:10.1002/(sici)1099-1077(199804)13:3<191::aid-hup972>3.0.co;2-x

Cited by 216 publications

(129 citation statements)

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“…57,59,60,70,[72][73][74][75][76][77][78][79] The overall quality of evidence was downgraded to very low due to significant heterogeneity, imprecision, and risk of publication bias. The evidence for zolpidem 10 mg was weakly in favor of its effectiveness for improving sleep onset, sleep maintenance, sleep quality, SE and TST.…”

Section: Discussionmentioning

confidence: 96%

“…Ten studies presented patient-reported sleep latency data. 57,60,70,[72][73][74][75][76]78,82 The mean reduction in subjective latency fell approximately at the significance threshold. Two studies 73,76 reported adequate objective TST data for metaanalysis and found that the mean improvement in TST also exceeded the clinical significance threshold.…”

Section: Discussionmentioning

confidence: 99%

“…57,70,[73][74][75][76]78,82 Two studies 73,76 found that PSG-determined reduction in WASO was clinically significant. Six studies included adequate data for meta-analysis of subjective WASO 57,72,75,76,78,82 ; the mean reduction fell below the clinical significance threshold. Six studies evaluating sleep quality reported moderately large improvement in this parameter based on SMD.…”

Section: Discussionmentioning

confidence: 99%

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0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Sateia

Buysse

Krystal

et al. 2017

Sleep

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Introduction:The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. Methods: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. Recommendations:The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading the quality of evidence for these treatments is predictable in GRADE, due to the funding source for most pharmacological clinical trials and the attendant risk of publication bias; the relatively small number of eligible trials for each individual agent; and the observed heterogeneity in the data. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources.1. We suggest that clinicians use suvorexant as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 2. We suggest that clinicians use eszopiclone as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK) 3. We suggest that clinicians use zaleplon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK) 4. We suggest that clinicians use zolpidem as a treatment for sleep onset and sleep maintenance in...

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Sateia

Buysse

Krystal

et al. 2017

Sleep

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“…A review of the literature indicates that there are no studies in primary insomnia with amitryptoline or mirtazepne, and there are only 2 studies with trazodone [79,80]. Trazodone (150 mg) failed to reduce sleep latency or increase total sleep time, although it did decrease wake after sleep onset for the 3-week study [79].…”

Section: Antidepressantsmentioning

confidence: 99%

“…Trazodone (150 mg) failed to reduce sleep latency or increase total sleep time, although it did decrease wake after sleep onset for the 3-week study [79]. In contrast, trazodone at a threefold lower dose (50 mg) reduced sleep latency and increased total sleep time, but the effect on total sleep time was present for only 1 week [80]. The inconsistency in dose effects on total sleep time and the apparent tolerance development raise concerns regarding the dose-related effects of trazodone as a hypnotic.…”

Section: Antidepressantsmentioning

confidence: 99%

Insomnia Pharmacotherapy

2012

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Summary The benzodiazepine receptor agonists (BzRAs) a melatonin receptor agonist and a histamine antagonist have all been approved as hypnotics. Beyond their differing mechanisms of action, they have differences in pharmacokinetics, and among the BzRAs differences in receptor subtype affinity and formulations, which provides the physician with broad options for tailoring therapy to each patient's specific needs. Consistent with their specific pharmacokinetics and formulations, these Food and Drug Administration-approved hypnotics have been shown to improve sleep with no evidence of tolerance development in long-term use. In addition, emerging data indicate these drugs also improve aspects of daytime function. Their side effects are either associated with the direct sedating effects of the drugs, doses greater than clinical doses, or a combination with alcohol or other sedating drugs. Anxiolytic BzRAs, sedating antidepressants and antipsychotics have been used off-label as hypnotics. However, in the absence of information regarding their dose range for efficacy and safety, their use as hypnotics is ill-advised.

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Insomnia

Buysse¹

2013

JAMA

811

556

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Key Clinical Question-How does one diagnose and treat insomnia in adults?Evidence Review-Summary of meta-analyses of chronic insomnia treatments.Bottom Line-Insomnia is a common clinical condition characterized by difficulty initiating or maintaining sleep, accompanied by symptoms such as irritability or fatigue during wakefulness. The prevalence of insomnia disorder is approximately 10-20%, with approximately 50% having a chronic course. Insomnia is a risk factor for impaired function, the development of other medical and mental disorders, and increased health care costs. The etiology and pathophysiology of insomnia involve genetic, environmental, behavioral, and physiological factors culminating in hyperarousal. Efficacious treatments for insomnia include behavioral, cognitive, and pharmacologic interventions. Simple behavioral interventions are feasible in primary care settings, but lack of training in these techniques limits their use. Among pharmacologic interventions, the most evidence exists for benzodiazepine receptor agonist drugs, although persistent concerns focus on their safety relative to modest efficacy. Behavioral treatments should be used whenever possible, and medications should be limited to the lowest necessary dose and shortest necessary duration. Dr. ShipMs. J is a 51-year-old woman with insomnia, which began at age 35 when her infant daughter had very disrupted sleep. By the age of 7, her daughter's sleep was improved, but Ms. J's was not. She was able to fall asleep, but was unable to stay asleep after about 3 in the morning. Ms. J tried several medications with variable success and side effects. She currently takes gabapentin, which is working well. She is very attentive to "sleep hygiene," and maintains a regular bedtime and waking time. M.s J's past medical history is notable for mild depression, Raynaud's Syndrome and myelodysplasia/myelofibrosis. Ms. J works as an educational consultant. She lives with her husband and two teenage children. She exercises regularly by swimming, cycling, and running. She does not use tobacco and has 1/2 glass of wine 3 nights per week. Current medications include escitalopram 20 mg daily, gabapentin 1200 mg qhs, and nifedipine SR 60 mg daily in cold weather. Ms. J has no drug allergies. On physical examination, Ms. J is healthy and fit. Weight is 121 pounds, blood pressure 119/64, and pulse 68 beats per minute.

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Subjective hypnotic efficacy of trazodone and zolpidem in DSMIII-R primary insomnia

Cited by 216 publications

References 9 publications

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

0395 Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline

Insomnia Pharmacotherapy

Insomnia

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