CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Zolpidem +1 moredrug
Likely dose
Zolpidem 10 mgAI-extracted
Key inclusion· 4
  • ✓Age 25–55 years
  • ✓Primary insomnia meeting diagnostic criteria for Psychophysiologic Insomnia per ICSD manual
  • ✓Sleep disturbance characteristics: >30 min to fall asleep and/or >30 min awake after sleep onset, total sleep time ≤6.5 hours (or sleep efficiency <85%), occurring >4 nights/week for >6 months
  • ✓Stable sleep/wake schedule with preferred sleep phase between 10:00 p.m. and 8:00 a.m.
Key exclusion· 7
  • ✕Unstable medical or psychiatric illness
  • ✕Concurrent medications that may cause insomnia or reduce zolpidem effectiveness (SSRIs, steroids, bronchodilators, calcium channel blockers, beta blockers)
  • ✕Symptoms or polysomnographic evidence of sleep disorders other than insomnia
  • ✕Active illicit substance use or meeting criteria for alcohol abuse/dependence

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00156533
NCT00156533Phase 4Completed
CompareCT.gov

Long Term Treatment With Zolpidem: The Relative Efficacy of Nightly (Quaque Hora Somni [QHS]) & Intermittent Dosing and the Potential for Long Term Clinical Gains After Treatment Discontinuation.

University of Rochester·interventional·Posted Sep 12, 2005·Updated Nov 20, 2015

In Brief

A Phase 4 clinical trial evaluating Zolpidem and Sugar Pill for Insomnia and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

We want to assess whether "how and when" one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Primary Insomnia, Psychophysiologic Insomnia
CountriesUnited States
CollaboratorsSanofi-Synthelabo

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartMar 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

Zolpidemdrug

10 mg of Zolpidem

Sugar Pilldrug