Eight Weeks of Non-Nightly Use of Zolpidem for Primary Insomnia

Walsh, James K.; Roth, Thomas; Randazzo, Angela C.; Erman, Milton K.; Jamieson, Andrew O.; Scharf, Martin B.; Schweitzer, Paula K.; Ware, J. Catesby

doi:10.1093/sleep/23.8.1h

Cited by 142 publications

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“…A significant effect of a placebo pill was found during an 8-week study aimed at investigating the effects of the intermittent use of zolpidem on primary insomnia (Walsh et al 2000). This study showed a progressive trend for better sleep in the placebo group, as assessed by subjective estimates across the duration of the study, both during on-pill nights and no-pill nights.…”

Section: Introductionmentioning

confidence: 84%

Can an inert sleeping pill affect sleep? Effects on polysomnographic, behavioral and subjective measures

et al. 2005

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The administration of an inert pill improves both the subjective and objective quality of sleep. The reduced sleep fragmentation and the effects on some quantitative EEG markers of sleep homeostasis suggest that the experimental manipulation induced coherent changes in the subsequent sleep, resembling an enhancement of sleep pressure. The regional differences of EEG activity suggest the involvement of a specific physiological mechanism distinct from that of effective treatments.

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Section: Introductionmentioning

confidence: 84%

Can an inert sleeping pill affect sleep? Effects on polysomnographic, behavioral and subjective measures

et al. 2005

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“…Erman Fourteen additional studies met inclusion criteria but could not be included in meta-analysis due to inadequate data sets. 71,[83][84][85][86][87][88][89][90][91][92][93][94][95] Pertinent results from these studies are noted independently of meta-analysis results.…”

Section: Discussionmentioning

confidence: 99%

“…57 [88][89][90]92,94,95 These studies varied significantly with regard to drug preparation, dosage, mode of administration and methodology, rendering comparisons between them or to the meta-analytic data difficult. Four of the six evaluated sublingual zolpidem, primarily for treatment of middle-of-the-night (MOTN) awakenings.…”

Section: Sleep Latencymentioning

confidence: 99%

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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“…Non-nightly treatment regimens (i.e., every third night or as needed) have been studied in several controlled trials. Non-nightly zolpidem was effective on the nights it was taken and on the off nights rebound insomnia was not experienced [94]. Non-nightly treatment regimens have been suggested due to concerns in regard to tolerance development and the development of physical/ behavioral dependence.…”

Section: Specific Nature Of Insomnia and Patient Characteristicsmentioning

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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Eight Weeks of Non-Nightly Use of Zolpidem for Primary Insomnia

Cited by 142 publications

References 0 publications

Can an inert sleeping pill affect sleep? Effects on polysomnographic, behavioral and subjective measures

Can an inert sleeping pill affect sleep? Effects on polysomnographic, behavioral and subjective measures

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

Insomnia Pharmacotherapy

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