The Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia study aims to test the effectiveness of the drug zolpidem for treating insomnia.
The study will be divided into three phases. All participants will take zolpidem nightly for one month. If the patient responds to treatment, they will continue with the study and will be assigned to a category: intermittent dosing, which involves taking 3-5 pills a week at full dose, or one of three variable dose categories, which involves taking a pill nightly at a variable dose.
Standard treatment will be 4 weeks while a subsequent experimental phase will last for two periods: one of 12 weeks and another of 36 weeks. This experimental phase will involve changing drug dosages, completing a daily sleep diary, filling out questionnaires and receiving the next dose of medication.
The final stages of the study will involve a physical examination.
- Has chronic insomnia and meets DSM-5 criteria for Insomnia Disorder, ICSD-3, and RDC criteria for Psychophysiologic Insomnia.
- Must take 30 minutes or longer to fall asleep or have 30-minute awake periods during the night, for at least three times per week.
- Currently being treated for insomnia
- Has unsuccessfully attempted treatment with zolpidem in the past
- Has stopped taking zolpidem in the past due to side effects
- Has any history of parasomnias within the last 5 years
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors / Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Clinical TrialsView All Clinical Trials
Brief Telehealth CBT-I Intervention in the Context of the COVID-19 Pandemic
The Brief Telehealth CBT-I Intervention in the Context of the COVID-19…
Therapist-Directed VS Online Therapy for Insomnia Co-Occurring With Sleep Apnea
The Therapist-Directed VS Online Therapy for Insomnia Co-Occurring With…
Sleep To Reduce Incident Depression Effectively
The Sleep To Reduce Incident Depression Effectively
Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
The Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis…
The EMS Sleep Health Study: A Randomized Controlled Trial
The EMS Sleep Health Study: A Randomized Controlled Trial aims to…
Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease
The Internet Cognitive Behavioral Therapy for Insomnia to Prevent…
Cognitive Behavioral Therapy for Insomnia With rTMS
The Cognitive Behavioral Therapy for Insomnia With rTMS
Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia
The Comparison of Efficacy of Behavioral Approaches for Treatment of…