Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The study is a three phase sequential study of the medical treatment of insomnia with zolpidem. All participating subjects will receive one month of standard nightly treatment. If the subject has a positive treatment response they continue in the study and are randomized to one of four conditions: intermittent dosing (3-5 pills week, full dose), or one of three variable dose conditions (nightly pill use where any given pill is a variable dose). Standard treatment will last for 4 weeks. The experimental phase will extend over two periods. The first period will last for 12 weeks. The second period will last for 36 weeks. Both periods include:

• Taking a pill 30 minutes prior to bedtime.

In one case, this will involve taking 3-5 pills per week. In the remaining condition pills will be taken on each and every night. Depending on the specific group that the subject is assigned to, they will either receive 10mg or 5mg of zolpidem (variable by age and sex) or a variable dose of zolpidem on a nightly basis (range from 0 mg to 10 mg per night).

• Completing a sleep diary each day;

• Completing 6 to 7 questionnaires each week;

• A monthly visit to Penn to return your medication foil packs and to receive a new foil pack with the next month of medication.

During Phases 3&4, the subject will be asked to undergo quarter annual physicals so that we can optimally track their health and wellbeing. The physicals will involve standard vitals measures (e.g., temperature, blood pressure, height and weight, etc.) and, based on the judgement of the research clinician, may involve an EKG and blood and urine chemistries.

If the subject does not experience a treatment response or (following a treatment response) experiences a relapse of insomnia, they will not continue in the study but will be given the opportunity to be treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) at no cost. Assessments of the subjects clinical status will be based on your daily sleep diaries and weekly questionnaires.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA); National Institutes of Health (NIH)
• Treatments: Zolpidem

Criteria

Inclusion Criteria:

• Patients with chronic insomnia will meet DSM-5 criteria for Insomnia Disorder, ICSD-3, and RDC criteria for Psychophysiologic Insomnia. In addition, all subjects will have a sleep initiation and/or a sleep maintenance complaint (> 30 min. to fall asleep and/or > 30 min. of wakefulness during the night) with a problem frequency > 3 nights/wk and problem duration > 3 mo. This profile must be evident at both intake (based on retrospective reports) and as an average profile from the two weeks of baseline diaries (prospective sampling).

Exclusion Criteria:

• currently in treatment for insomnia, unstable medical or psychiatric illness, a history of treatment failure with zolpidem, discontinuation of zolpidem owing to side effects, and/or current experience, or history, of parasomnias (within the last 5 years).