Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)

Inclusion Criteria

• are at least 65 years of age at screening;
• sign written informed consent after the scope and

nature of the investigation have been explained to

them, before screening evaluations;

• are able to speak, read and understand the language of

the investigator, study staff (including raters) and the

informed consent form, and possess the ability to

respond to questions, follow instructions and complete

questionnaires;

• have demonstrated capability to independently

complete the LogPad questionnaires and have

completed the questionnaires at least 6 out of 7 days of

the week preceding randomization;

• have a regular sleep pattern, meaning bedtime regularly

occurs between 2100 hours and 2400 hours, with no more variation

from these boundaries than 2 times/ week, with 5-8.5

hours in bed;

• have a documented diagnosis of chronic primary

insomnia, defined as fulfillment of the Diagnostic and Statistical Manual of Mental Disorders IV - Text Revision (DSM-IV-TR) criteria

for primary insomnia (DSM-IV-TR 307.42) with a duration

of >= 1 month; fulfill the following PSG criteria on the

two screening/baseline PSG nights:

• average Total Sleep Time (TST) 15 cigarettes per day and/or can not abstain from smoking during the night;
• drink excessive amounts of caffeinated beverages/day (more than 500 mg caffeine per day);
• have a body mass index (BMI) >= 36;
• have a positive urine drug screen at screening or at baseline;
• have a known hypersensitivity to mirtazapine or to any of the excipients;