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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Zolpidem

Criteria

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