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Related Experiment Videos

Zolpidem extended-release.

Marit D Moen1, Greg L Plosker

  • 1Adis International Limited, Mairangi Bay, Auckland, New Zealand. demail@adis.co.nz

CNS Drugs
|May 16, 2006
PubMed
Summary
This summary is machine-generated.

Zolpidem controlled-release (CR) effectively treats insomnia by improving sleep onset and maintenance. This new formulation demonstrated significant objective and subjective sleep improvements in adult and elderly patients compared to placebo.

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Area of Science:

  • Pharmacology
  • Sleep Medicine
  • Clinical Trials

Background:

  • Zolpidem is a nonbenzodiazepine hypnotic used for insomnia.
  • Insomnia is characterized by difficulties with sleep onset and/or maintenance.
  • A new controlled-release (CR) formulation of zolpidem has been developed.

Purpose of the Study:

  • To assess the efficacy and tolerability of zolpidem CR in treating primary insomnia.
  • To evaluate the dual-layered tablet's ability to manage sleep onset and maintenance.
  • To compare zolpidem CR with placebo in adult and elderly populations.

Main Methods:

  • Two 3-week, randomized, double-blind, placebo-controlled, phase III polysomnography trials were conducted.
  • Participants included younger adults (18-64 years) and elderly patients (≥65 years) with primary insomnia.

Related Experiment Videos

  • Objective efficacy was measured by sleep latency, wake time, and sleep efficiency; subjective efficacy by patient global impression.

    • Main Results:

    • Zolpidem CR significantly improved objective measures of sleep, including latency to persistent sleep, wake time after sleep onset, and sleep efficiency.
    • A greater proportion of zolpidem CR recipients reported improved sleep quality compared to placebo recipients in both younger adult and elderly groups.
    • Zolpidem CR was generally well tolerated, with a similar profile to the original zolpidem formulation.

    Conclusions:

    • Zolpidem CR is an effective treatment for primary insomnia, addressing both sleep onset and maintenance issues.
    • The dual-layer tablet design facilitates immediate and sustained release of zolpidem.
    • Zolpidem CR offers a favorable efficacy and tolerability profile for managing insomnia in diverse adult populations.