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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181232

Enrollment

132

Registered

2010-08-13

Start date

2009-10-31

Completion date

2011-04-30

Last updated

2014-09-10

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

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.

Interventions

DRUGZolpidem MR

oral

DRUGZolpidem IR

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 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

Design outcomes

Primary

Measure	Time frame
Rest/activity cycles measured by Actigraphy	For 2 weeks (Day 0, Day 7, Day 14)
Total score of Pittsburgh Sleep Quality Index (PSQI)	For 2 weeks (Day 0, Day 7, Day 14)

Secondary

Measure	Time frame
Sleep latency as derived from sleep diary	For 2 weeks (Day 0, Day 7, Day 14)
Number of awakenings as derived from sleep diary	For 2 weeks (Day 0, Day 7, Day 14)
Physician's clinical global impression (CGI)	For 2 weeks (Day 0, Day 7, Day 14)
Wake time after sleep onset as derived from sleep diary	For 2 weeks (Day 0, Day 7, Day 14)
Day time function as assessed by Epworth Sleepiness Scale (ESS)	For 2 weeks (Day 0, Day 7, Day 14)
Total sleep time as derived from sleep diary	For 2 weeks (Day 0, Day 7, Day 14)
Patient's global impression (PGI)	For 2 weeks (Day 0, Day 7, Day 14)

Countries

Taiwan

Outcome results

None listed

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