Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg, Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study

Krystal, Andrew D.; Erman, Milton K.; Zammit, Gary; Soubrane, Christina; Roth, Thomas

doi:10.1093/sleep/31.1.79

Cited by 201 publications

(101 citation statements)

References 24 publications

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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%

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: 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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show abstract

“…It has been shown that the eszopiclone can exhibit different binding properties on GABA A receptor, compared to zolpidem it is also less selective for the GABA A receptor α 1 -subunit. 11 Also in a double-blind, randomized, placebo-controlled trial it improved daytime functioning at a dose of 3 mg without evidence of tolerance, dependence, or abuse.…”

Section: Eszopiclonementioning

confidence: 97%

Pharmacotherapeutic options for treatment of insomnia

Singh

2014

Int J Basic Clin Pharmacol

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“…Four trials studied the general adult population with pain [80][81][82][83][84] and three assessed the efficacy of CBT-I in older adults with pain. 79,85,86 McCurry is a second publication of an earlier trial analyzing only a portion of the participants with pain.…”

Section: Overview Of Studiesmentioning

confidence: 99%

Cognitive Behavioral Therapy in the Treatment of Insomnia

Haynes¹,

Talbert²,

Fox³

et al. 2018

Southern Medical Journal

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Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg, Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study

Abstract: These findings establish the efficacy of 3 to 7 nights per week dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness.

Cited by 201 publications

References 24 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

Pharmacotherapeutic options for treatment of insomnia

Cognitive Behavioral Therapy in the Treatment of Insomnia

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