The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
222
UNIFAG - Casa Nossa Senhora da PAZ -ASF
Bragança Paulista, São Paulo, Brazil
RECRUITINGReduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography
Time frame: Change from baseline after 2 weeks of treatment
Adverse events incidence and classification
Time frame: Through study completion, up to 6 weeks
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APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1
Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4
placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1