Clinical trialNCT00878553CompletedPhase 2Interventional

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

SponsorSomnus Therapeutics, Inc.Enrollment67Primary InsomniaSleep Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Beth E. Safirstein, MD
MD Clinical
Principal Investigator
clinicaltrials.gov ↗
D. Alan Lankford, PhD
Sleep Disorders Center of Georgia
Principal Investigator
clinicaltrials.gov ↗
David J. Seiden, MD
Broward Research Group
Principal Investigator
clinicaltrials.gov ↗
Helene A. Emsellem, MD
Emsellem MD PC
Principal Investigator
clinicaltrials.gov ↗
James K. Walsh, PhD
Sleep Medicine and Research Center
Principal Investigator
clinicaltrials.gov ↗
Jon Freeman, PhD
Clinilabs, Inc.
Principal Investigator
clinicaltrials.gov ↗
Russell Rosenberg, PhD
Neurotrials Inc.
Principal Investigator
clinicaltrials.gov ↗
Steven G. Hull, MD
Vince and Associates Clinical Research
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

SKP-1041Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2010
Primary completion: 31 Dec 2010
Completion: 31 Aug 2011
Last update posted: 1 Feb 2013
Registered enrollment: 67
Registry id: NCT00878553

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.