Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia

The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

Inclusion Criteria:

• Has signed written informed consent after the scope and nature of the investigation was explained to them
• Has difficulty falling asleep, maintaining sleep or has early morning awakenings

Exclusion Criteria:

• Significant medical or psychiatric illness causing sleep disturbances
• Has a history of bipolar disorder or family (immediate family) of suicide
• Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy
• Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year
• Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years
• Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.