Sleep Initiation and Maintenance Disorders, Sleep Disorders
Conditions
Keywords
zolpidem, sleep initiation and maintenance disorders Hypnotics and sedatives, double-blind study, comparative study
Brief summary
The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using zolpidem (Myslee) as a comparative drug
Interventions
DRUGZolpidem MR
Oral
DRUGZolpidem
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of nonorganic insomnia. * Must be able to swallow tablets
Exclusion criteria
* Allergic reactions to zolpidem (Myslee) * Serious cardiac disorders; Serious hepatic impairment; Serious renal diseases, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean wake time after sleep onset during the double-blind period | 2 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean total sleep time during the double-blind period | 2 Weeks |
| Mean number of nightly awakenings during the double-blind period | 2 Weeks |
| Mean sleep latency during the double-blind period | 2 Weeks |
| Patient impression during the double-blind period | 2 Weeks |
| Safety | 2 Weeks |
Countries
Japan
Outcome results
None listed