A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia

FK199B (Zolpidem MR Tablet) Phase III Clinical Study - A Double-Blind, Crossover, Comparative Polysomnographic Study Using Zolpidem (Myslee®) as a Positive Control in Patients With Insomnia, Excluding Patients With Schizophrenia or Manic-Depressive Psychosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00999219

Enrollment

Registered

2009-10-21

Start date

2006-03-31

Completion date

2007-07-31

Last updated

2014-08-20

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

Keywords

FK199B, Zolpidem

Brief summary

This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by polysomnography in patients with insomnia, excluding patients with schizophrenia or manic-depressive psychosis.

Interventions

DRUGFK199B

oral

DRUGZolpidem

oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) * Patients complaining of insomnia continuously for 4 weeks or longer * Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening * Patient on most occasions sleeps for a total of ≥3 and \<6.5 hours over the 4 week period prior to initial screening * Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening * Patients have a body weight of ≥45 kg and ≤85 kg, a BMI of ≥18.5 and \<30

Exclusion criteria

* Patients with schizophrenia or manic-depressive psychosis * Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic * Patients with circadian rhythm sleep disorder * Patient works night shifts * Patients with alcoholic sleep disorder * Patients with alcohol or drug dependence or a history of these * Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs * Patients with sleep apnea syndrome * Patients with restless legs syndrome or periodic limb movement disorder * Patients with epileptic insomnia * Patients smoke on average 40 or more cigarettes a day * Patients who had received psychotropic drugs other than hypnotics (including anxiolytic or antidepressant drugs for hypnotic effect) within a 4 week period prior to the initial screening

Design outcomes

Primary

Measure	Time frame
Sleep parameters estimated from polysomnography recording (wake time after sleep onset and number of awakenings)	8 hours

Secondary

Measure	Time frame
Mean sleep parameters estimated from polysomnography recording	8 hours
Sleep parameters estimated from sleep questionnaire	After each night of sleep during the study period
Patient impression from sleep questionnaire	After each night of sleep during the study period

Countries

Japan

Outcome results

None listed

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