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

Astellas

Status and phase

Completed

Phase 3

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Drug: FK199B

Drug: Zolpidem

Study type

Interventional

Funder types

Industry

Identifiers

NCT00999219

6199-CL-0006

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No 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