An Exploratory Study of NBI-34060 Capsules and Next Day Functioning

• Status: Withdrawn
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurocrine Biosciences
• Treatments: Indiplon

Criteria

Inclusion Criteria:

• insomnia (DSM-IV diagnosed; at least one month)

• Nocturnal awakenings

• Usual bedtimes between 9:00PM and Midnight.

• Bedtimes that do not vary by more than 2 hours on 5 or more nights per week.

• A usual time in bed of 7 to 9 hours.

Exclusion Criteria:

• no serious concomitant illness

• no other condition that could interfere with sleep