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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956319

Enrollment

Registered

2009-08-11

Start date

2009-05-31

Completion date

2010-11-30

Last updated

2011-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Initiation and Maintenance Disorders, Primary Insomnia

Keywords

Insomnia, Zolpidem, Estazolam

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.

Interventions

DRUGZolpidem MR

oral

DRUGEstazolam

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total score of Pittsburgh Sleep Quality Index (PSQ)	3 weeks

Secondary

Measure	Time frame
Physician's clinical global impression (CGI)	3 weeks
Patient's global impression (PG)	3 weeks
Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary	3 weeks
Incidence and severity of adverse events, including abnormal sleep behavior	3 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026