Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Ramelteon and zolpidem; Placebo and zolpidem
Intervention description: Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.; Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
Intervention MeSH terms: Zolpidem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Insomnia; Sleep Initiation and Maintenance Disorder; Drug Therapy

Summary:

      The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the
      discontinuation of zolpidem in subjects with chronic insomnia.
    

Eligibility criteria:

        Inclusion Criteria

          -  Chronic insomnia and taking greater than or equal to 10 mg zolpidem at least 4 times
             per week.

          -  Has been prescribed zolpidem for difficulty in initiating sleep.

          -  Must report chronic use of zolpidem greater than or equal to10 mg therapy for a
             minimum of 3 months prior to entry into Period 1 of the study.

          -  Must have taken zolpidem greater than or equal to 10 mg therapy for at least 4 of 7
             days each week of the 4 weeks immediately prior to entry into the double blind phase,
             Period 2.

          -  Expressed a willingness to discontinue zolpidem therapy.

          -  Habitual bedtime is between 9:00 PM and 1:00 AM based on sleep history.

          -  Negative test result for hepatitis B surface antigen and hepatitis C virus antibody.

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

        Exclusion Criteria

          -  Known hypersensitivity to ramelteon, zolpidem, or melatonin.

          -  Participated in any other investigational study and/or taken any investigational drug
             within 30 days prior to the first dose of run-in study medication.

          -  Sleep schedule changes required by employment (eg, shift worker) within 3 months prior
             to the first night of run-in study medication.

          -  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.

          -  History of drug addiction or drug abuse within the past 12 months.

          -  History of alcohol abuse within the past 12 months, as defined in Diagnostic and
             Statistical Manual of Mental Disorders, 4th Edition revised and/or regularly consumes
             more than 2 alcoholic drinks per day.

          -  Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal,
             pulmonary, hematological, or metabolic disease, unless currently controlled and stable
             with protocol-allowed medication, within 30 days prior to the first night of run-in
             study medication.

          -  Body mass index of less than 18 or greater than 34 (weight /height2).

          -  Any clinically important abnormal finding as documented by a medical history, physical
             examination, electrocardiogram, or clinical laboratory tests, as determined by the
             investigator.

          -  Positive hepatitis panel.

          -  Known history of human immunodeficiency virus.

          -  Any additional conditions(s) that in the investigator's opinion would affect:

               -  sleep/wake function

               -  prohibit the subject from completing the study

               -  indicate that continuation in the study would not be in the best interests of the
                  subject.

          -  Is required to take or continues taking any disallowed medication, prescription
             medication, herbal treatment or over-the counter medication, including:

               -  Melatonin

               -  Anxiolytics

               -  Antipsychotics

               -  Over-the-counter and prescription sedatives

               -  Hypnotics (excluding zolpidem)

               -  Narcotic analgesics

               -  Antidepressants

               -  Beta-blockers (exception is that Atenolol is permissible)

               -  Anticonvulsants

               -  St. John's wort

               -  Sedating H1 antihistamines

               -  Kava-kava

               -  Systemic steroids

               -  Ginkgo-biloba

               -  Respiratory stimulants

               -  Over-the-counter and prescription diet aids

               -  Sedating Decongestants