Efficacy of Ramelteon on Insomnia Symptoms Associated With Jet Lag in Healthy Adult Volunteers

Inclusion Criteria * Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. * Willing to travel from Hawaii to the East Coast and have a minimum stay of 6 days at the destination in a sleep laboratory during the entire study. * Has lived in Hawaii for at least 12 months and has not been traveling outside of Hawaii for 4 consecutive days within 30 days prior to the Outpatient Screening Visit. * History of sleep disturbance associated with jet lag symptoms, with at least two occurrences in the last three years, as defined in the International Classification of Sleep Disorders. * Habitual bedtime should be determined by sleep history as between 9:00 PM and 12:00 AM as determined by sleep history prior to randomization. * Have regular bedtime (within 1 hour) for 1 week prior to travel. * The subject has a subjective sleep latency of less than 30 minutes and a subjective total sleep time of 6.5 hours but less than 9 hours, as determined by sleep history. * Mean subjective sleep latency of less than 30 minutes and a mean subjective total sleep time of greater than 6.5 hours but less than 9 hours in 3 of 5 nights after the outpatient screening visit, as determined by post-sleep questionnaire. * Willingness and ability to comply with study procedures, including travel time, sleep, and waking-hour activities, light-exposure restriction, and food …