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

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

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Astellas Pharma Inc

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

Overall contact:
Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com

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.

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

Primary outcome:

Rest/activity cycles measured by Actigraphy

Total score of Pittsburgh Sleep Quality Index (PSQI)

Secondary outcome:

Physician's clinical global impression (CGI)

Patient's global impression (PGI)

Sleep latency as derived from sleep diary

Number of awakenings as derived from sleep diary

Total sleep time as derived from sleep diary

Wake time after sleep onset as derived from sleep diary

Day time function as assessed by Epworth Sleepiness Scale (ESS)

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

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

Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com

Tainan 704, Taiwan; Recruiting

Taipei 100, Taiwan; Recruiting

Starting date: October 2009
Last updated: August 12, 2010