COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 24 of 138 for:    ZOLPIDEM

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00956319
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : October 6, 2011
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Primary Insomnia Drug: Zolpidem MR Drug: Estazolam Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) in Patients With Primary Insomnia
Study Start Date : May 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zolpidem group Drug: Zolpidem MR
Other Names:
  • Stilnox CR
  • Ambient CR

Active Comparator: Estazolam group Drug: Estazolam
Other Name: Eurodin

Primary Outcome Measures :
  1. Total score of Pittsburgh Sleep Quality Index (PSQ) [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Physician's clinical global impression (CGI) [ Time Frame: 3 weeks ]
  2. Patient's global impression (PG) [ Time Frame: 3 weeks ]
  3. Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary [ Time Frame: 3 weeks ]
  4. Incidence and severity of adverse events, including abnormal sleep behavior [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00956319

Layout table for location information
Taipei, Taiwan, 100
Sponsors and Collaborators
Astellas Pharma Inc
Layout table for investigator information
Study Chair: Use Central Contact Astellas Pharma Inc
Layout table for additonal information
Responsible Party: Astellas Pharma Inc Identifier: NCT00956319    
Other Study ID Numbers: STCR-0802-TW
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators