A Phase 4 interventional study of zolpidem in Insomnia and Sleep Initiation and Maintenance Disorders, sponsored by Astellas Pharma Inc. Completed at 4 sites in Japan. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-02-17.
Sponsored by Astellas Pharma Inc · Phase 4, Interventional, and Treatment
To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
The study consists of two parts. All patients will receive placebo in one part and Zolpidem in the other part in a single blind manner. Efficacy will be measured with polysomnography .
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 11 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive placebo in one part and zolpidem in the other part
Drug: zolpidem
Oral
Also known as: Myslee
Sleep latency
Time frame: 2 days
Total hours of sleep
Time frame: 2 days
Frequency of intermediate awaking
Time frame: 2 days
Time of intermediate awaking
Time frame: 2 days
Patient impression
Time frame: 2 days
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Astellas Pharma Inc