A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia

Astellas Pharma Inc876 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

876

Conditions

Sleep Initiation and Maintenance Disorders Sleep Disorders

Interventions

Zolpidem MRDRUG

Oral

ZolpidemDRUG

Oral

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (8)

Unnamed facility

Chubu Region, Japan

Unnamed facility

Chugoku Region, Japan

Unnamed facility

Hokkaido Region, Japan

Unnamed facility

Kansai Region, Japan

Unnamed facility

Outcomes

Primary Outcomes

Mean wake time after sleep onset during the double-blind period

Time frame: 2 Weeks

Secondary Outcomes

Mean total sleep time during the double-blind period

Time frame: 2 Weeks

Mean number of nightly awakenings during the double-blind period

Time frame: 2 Weeks

Mean sleep latency during the double-blind period

Time frame: 2 Weeks

Patient impression during the double-blind period

Time frame: 2 Weeks

Safety

Time frame: 2 Weeks

Data from ClinicalTrials.gov

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