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Sedative-Hypnotic

Zolpidem tartrate for Chronic Insomnia (R01 Trial)

Phase 4
Waitlist Available
Led By Michael L Perlis, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

R01 Trial Summary

This trial is a three-phase study of the medical treatment of insomnia with zolpidem, a sleep aid. Subjects will receive standard nightly treatment for one month, then be randomized to one of four conditions: intermittent dosing (3-5 pills per week), or one of three variable dose conditions (nightly pill use with a variable dose). Standard treatment will last for 4 weeks, then the experimental phase will extend over two periods, each 12 or 36 weeks long. Subjects will take a pill 30 minutes prior to bedtime and complete a sleep diary and questionnaires each day or week. There will be monthly visits to Penn to return medication

Eligible Conditions
  • Chronic Insomnia
  • Insomnia

R01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Relapse
Secondary outcome measures
Sleep Continuity

Side effects data

From 2018 Phase 3 trial • 1006 Patients • NCT02783729
5%
Headache
2%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Zolpidem Tartrate Extended Release 6.25 mg
Lemborexant 5 mg
Lemborexant 10 mg
Run -in Period Placebo

R01 Trial Design

4Treatment groups
Experimental Treatment
Group I: Partial Reinforcement 3Experimental Treatment1 Intervention
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Group II: Partial Reinforcement 1Experimental Treatment1 Intervention
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Group III: Low Frequency Intermittent DosingExperimental Treatment1 Intervention
1 to 3 active doses per week PRN. The intervention is zolpidem tartrate 5 mg or 10 mg.
Group IV: ContinuousExperimental Treatment1 Intervention
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zolpidem tartrate
2019
Completed Phase 4
~1210

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,382 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,865 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,890 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this experimental research?

"Affirmative. Clinicaltrials.gov data suggests that this trial, which was originally posted on April 15th 2019, is currently recruiting participants. 200 patients need to be enrolled from a single site."

Answered by AI

Has Zolpidem tartrate been sanctioned by the Federal Drug Administration?

"Zolpidem tartrate is approved for treatment, and has thus been given a safety ranking of 3."

Answered by AI

Has research been conducted on Zolpidem tartrate in the past?

"As it currently stands, there are 7 experiments researching Zolpidem tartrate with no Phase 3 trials. Of the 16 locations conducting this research, a concentration of sites can be found in Silver Spring, Maryland."

Answered by AI

Is this research initiative open to senior citizens over the age of 80?

"This medical study is intended for participants between 40 and 85 years old. For those under 18, there are 24 separate clinical trials; conversely, if one is over 65, 184 studies could be applicable."

Answered by AI

Is there an opportunity to be a participant in this experiment?

"This clinical trial seeks 200 participants aged 40 to 85 with a documented history of sleeplessness and insomnia. To qualify, individuals must meet the DSM-5 criteria for Insomnia Disorder, ICSD-3 requirements, and RDC qualifications for Psychophysiologic Insomnia. Moreover, registrants should expect at least 3 nights per week where it takes them over 30 minutes to fall asleep or experience more than 30 minutes of wakefulness during the night; this pattern must be visible in both retrospective reports from intake as well as prospective sampling via two weeks' worth of baseline diaries."

Answered by AI

Is this experimental program recruiting participants presently?

"The clinical trial is still recruiting, as evidenced by the latest update to its listing on clinicaltrials.gov which was posted on July 15th 2022. Initial recruitment began in April 2019."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Looking for any help with my chronic insomnia.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
2019. "Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03774810.
~33 spots leftby Apr 2025
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