Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Conditions

APSTZD 1 — DRUG
APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1
APSTZD 2 — DRUG
APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1
APSTZD 3 — DRUG
APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1
APSTZD 4 — DRUG
APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1
Stilnox CR® — DRUG
Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4
Placebo — DRUG
placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1

The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.

Experimental: APSTZD 1
5 oral tablets, once a day, before bedtime, for 6 weeks.
Experimental: APSTZD 2
5 oral tablets, once a day, before bedtime, for 6 weeks.
Experimental: APSTZD 3
5 oral tablets, once a day, before bedtime, for 6 weeks.
Experimental: APSTZD 4
5 oral tablets, once a day, before bedtime, for 6 weeks.
Active Comparator: Stilnox CR®
5 oral tablets, once a day, before bedtime, for 6 weeks.
Placebo Comparator: Placebo
5 oral tablets, once a day, before bedtime, for 6 weeks.

Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography [ Time Frame: Change from baseline after 2 weeks of treatment ]

Nationwide