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

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ClinicalTrials.gov Identifier: NCT01181232
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : September 10, 2014
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MR low-dose group Drug: Zolpidem MR
oral
Other Names:
  • Stilnox CR
  • Ambient CR
Experimental: MR high-dose group Drug: Zolpidem MR
oral
Other Names:
  • Stilnox CR
  • Ambient CR
Active Comparator: IR group Drug: Zolpidem IR
oral
Other Name: Stilnox


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01181232


Locations
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Taiwan
Tainan, Taiwan, 704
Taipei, Taiwan, 100
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Investigators
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Study Chair: Use Central Contact Astellas Pharma Inc
More Information
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Additional Information:

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01181232    
Other Study ID Numbers: STCR-0901-TW
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: August 2014
Keywords provided by Astellas Pharma Inc:
insomnia
zolpidem
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
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