Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

PHASE4CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

March 31, 2008

Study Completion Date

May 31, 2008

Conditions
Chronic Insomnia
Interventions
DRUG

Ramelteon and zolpidem

Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.

DRUG

Placebo and zolpidem

Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.

Trial Locations (41)

Unknown

Hot Springs

Anaheim

Fountain Valley

La Mesa

Los Angeles

Redlands

San Diego

San Francisco

Santa Monica

Denver

Clearwater

Hollywood

Kissimmee

Naples

Pembroke Pines

Winter Park

Atlanta

Austell

Boise

Louisville

Metairie

Chevy Chase

St Louis

Lincoln

New York

West Seneca

Raleigh

Wilmington

Cincinnati

Toledo

Portland

Philadelphia

Greer

Fayetteville

Austin

Dallas

Fort Worth

Houston

San Angelo

San Antonio

Salt Lake City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY