Official Title: “Randomized, Double Blind, Placebo-Controlled Study to Assess Whether the Administration of Ramelteon Could Facilitate the Discontinuation of Zolpidem (Ambien®) ≥10 mg Therapy in Subjects With Chronic Insomnia”

This study is designed to assess whether administration of ramelteon will facilitate the discontinuation of zolpidem in subjects with chronic insomnia. Subjects will receive placebo or ramelteon, in addition to decreasing doses of zolpidem, over the course of the study. At the end of the study, ramelteon will be compared with placebo with respect to the number of subjects who no longer require zolpidem therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

This is a phase 4, double-blind, randomized, placebo controlled study to assess whether administration of ramelteon will facilitate the discontinuation of zolpidem (Ambien®) therapy in subjects with chronic insomnia. For 4 weeks, subjects will take nightly single-blind medication, either zolpidem or study medication. For the next 10 weeks, subjects will take a nightly dose of double-blind study medication (ramelteon 8 mg or placebo). During this time, subjects will continue taking zolpidem, however the amount will be gradually reduced over the 10 week period. If after 10 weeks subjects are able to reduce their zolpidem by at least half (50%), they will continue for 2 additional weeks; during this time 8 mg of ramelteon will be administered once a day for 2 weeks. At the end of the study, ramelteon will be compared with placebo with respect to the number of subjects who no longer require zolpidem therapy.

Intervention(s) in this Clinical Trial

• Drug: Ramelteon
  • Ramelteon 8 mg tablet, orally, once daily for 10 weeks + variable dose of Zolpidem over a ten week period.
• Drug: Placebo
  • Placebo tablet, orally, once daily for 10 weeks + variable dose of Zolpidem over a ten week period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Ramelteon
• Placebo Comparator: 2
  • Placebo

Primary Measures

• To assess whether the administration of ramelteon nightly will facilitate the discontinuation of long-term use of zolpidem therapy in subjects with chronic insomnia.
  • Time Frame: Up to 16 Weeks
    Safety Issue?: No

Secondary Measures

• To identify the method of discontinuing zolpidem use, based on subject's voluntary choice which is most likely to lead to successful mean weekly dose reduction/cessation of zolpidem therapy when using ramelteon.
  • Time Frame: Up to 16 Weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female 18 years of age or older with chronic insomnia
• The subject has been prescribed zolpidem for difficulty in initiating sleep
• The subject must report chronic use of zolpidem ≥ 10mg therapy for a minimum of 3 months prior to entry into study, and subjects have expressed a willingness to discontinue their zolpidem therapy
• The subject's habitual bedtime is between 9 PM and 1 AM
• The subject is fluent in English (speaking, reading, writing)—for purpose of data collection

Exclusion Criteria:

• The subject has a known hypersensitivity to ramelteon or zolpidem or melatonin
• The subject has participated in any other investigational study and/or taken any investigational drug within 30 days
• The subject has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the start of the study
• The subject has a history of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder
• The subject has current significant disease, not currently controlled and stable with protocol-allowed medication
• Female subjects who are pregnant and/or lactating

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Takeda Global Research & Development Center, Inc.

Overall Clinical Trial Officials and Contacts

Sherry Weigand, MD, PhD Study Director Takeda Global Research & Development Center  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00492232

Study ID Number: 01-06-TL-375-071

ClinicalTrials.gov Identifier: NCT00492232

Health Authority: United States: Food and Drug Administration