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

Astellas

Status and phase: Completed; Phase 3

Conditions: Sleep Disorders; Sleep Initiation and Maintenance Disorders

Treatments: Drug: Zolpidem; Drug: Zolpidem MR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00283946

6199-CL-0007

Details and patient eligibility

About

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

Enrollment: 876 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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876 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Zolpidem MR

2

Active Comparator group

Treatment:

Drug: Zolpidem