Study of Sleep-maintenance Activity of 3 Doses of SKP-1041

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Somnus Therapeutics, Inc.
• Collaborator: INC Research Limited
• Treatments: Zaleplon

Criteria

Inclusion Criteria:

• Primary insomnia characterized by chronic difficulty maintaining sleep

Exclusion Criteria:

• History of restless legs syndrome, sleep apnea, narcolepsy, or parasomnias;

• Any clinically relevant acute or chronic diseases which could interfere with the patient's safety during this trial or with this tablet's absorption;

• Pregnancy;

• History of medication allergies;

• Use of medication that might interfere with this study;

• Recent travel across more than 3 time zones.