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NCT Number: NCT01181232

A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients

The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Primary Insomnia Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tainan, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
  • Written informed consent has been obtained

Exclusion criteria

  • Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
  • Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
  • Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
  • Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
  • Patients who are pregnant, lactating or intend to become pregnant during the study period
  • Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
  • Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
  • Participation in any clinical trial within 1 month prior to randomization

Treatment and study plan

Zolpidem MR

Drug

oral

Other names: Stilnox CR, Ambient CR

Zolpidem IR

Drug

oral

Other names: Stilnox

Primary outcomes

  1. Rest/activity cycles measured by Actigraphy

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

  2. Total score of Pittsburgh Sleep Quality Index (PSQI)

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

Secondary outcomes

  1. Physician's clinical global impression (CGI)

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

  2. Patient's global impression (PGI)

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

  3. Sleep latency as derived from sleep diary

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

  4. Number of awakenings as derived from sleep diary

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

  5. Total sleep time as derived from sleep diary

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

  6. Wake time after sleep onset as derived from sleep diary

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

  7. Day time function as assessed by Epworth Sleepiness Scale (ESS)

    Time frame: For 2 weeks (Day 0, Day 7, Day 14)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Taiwan, Inc.

Registry information

Official study title

A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary Insomnia

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2010
Registry last updated
Sep 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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