A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. It has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.

Inclusion criteria

• Documented diagnosis of chronic primary insomnia

Exclusion criteria

• Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
• Has significant medical or psychiatric illness as causing the sleep disorder
• Diagnosed with major depressive disorder
• Substance abuse within the past year
• Night worker or work on rotating shifts
• Has had serious head injury, stroke, epilepsy
• Has a history of bipolar disorder or family (immediate family) history of suicide
• Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
• Drinks beverages containing more than 500 mg caffeine per day