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

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring FK199B, Zolpidem Read More

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