Efficacy Study of EVT 201 to Treat Insomnia

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Efficacy of Two Doses of EVT 201 in the Treatment of Primary Insomnia in Adult Patients

The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).

Inclusion Criteria:

• must have a diagnosis of primary insomnia
• over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
• must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period
• must be willing and able to complete a sleep diary and questionnaires

Exclusion Criteria:

• must not have a clinically significant or unstable medical condition that may interfere with sleep
• must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder
• must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants
• must not intentionally nap 3 (or more) times per week
• must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)