Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)

Fifty-Two Weeks, Open Label Extension Trial to Evaluate Safety and Efficacy of Org 50081 in Outpatients With Chronic Primary Insomnia Who Completed Clinical Trial Protocol 176001 or 176002.

This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.

Inclusion Criteria:

• sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
• completed Protocol P05706 or P05707;
• Have safety and efficacy assessments conducted per protocol P05706 or P05707.

Exclusion Criteria:

• clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
• clinically relevant abnormal laboratory values as judged by the investigator;
• any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
• were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.