Articlegreen2012

Efficacy of Eight Months of Nightly Zolpidem: A Prospective Placebo-Controlled Study

Surilla Randall · Timothy Roehrs · Thomas G. Roth

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Abstract

STUDY OBJECTIVES: To evaluate the long-term (8 months) efficacy of zolpidem in adults with chronic primary insomnia using polysomnography. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Sleep disorders and research center. PARTICIPANTS: Healthy participants (n = 91), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia. INTERVENTIONS: Nightly zolpidem, 10 mg (5 mg for patients > 60 yrs) or placebo 30 minutes before bedtime for 8 months. MEASUREMENTS AND RESULTS: Polysomnographic sleep parameters and morning subject assessments of sleep on 2 nights in months 1 and 8. Relative to placebo, zolpidem significantly increased overall total sleep time and sleep efficiency, reduced sleep latency and wake after sleep onset when assessed at months 1 and 8. Overall, subjective evaluations of efficacy were not shown among treatment groups. CONCLUSIONS: In adults with primary insomnia, nightly zolpidem administration remained efficacious across 8 months of nightly use. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525.

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1968A manual for standardized terminology, techniques and scoring system for sleep stages in human subjects 1969A manual of standardized terminology, techniques and scoring system for sleep stages of human subjects 2007Insomnia: Definition, Prevalence, Etiology, and Consequences 2005National Institutes of Health State of the Science Conference Statement 2003Sustained Efficacy of Eszopiclone Over 6 Months of Nightly Treatment: Results of a Randomized, Double-Blind, Placebo-Controlled Study in Adults with Chronic Insomnia 1982Sleeping and waking disorders : indications and techniques 2000Evaluation of Chronic Insomnia 2000Practice Parameters for the Evaluation of Chronic Insomnia

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