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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Initiation and Maintenance Disorders; Primary Insomnia

Intervention: Zolpidem MR (Drug); Estazolam (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Total score of Pittsburgh Sleep Quality Index (PSQ)

Secondary outcome:

Physician's clinical global impression (CGI)

Patient's global impression (PG)

Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary

Incidence and severity of adverse events, including abnormal sleep behavior


Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.


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


- 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

Locations and Contacts

Taipei 100, Taiwan
Additional Information

Starting date: May 2009
Last updated: October 5, 2011

Page last updated: August 23, 2015

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