Phase 4 Completed N=205 Randomized Double-blind Treatment

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

Insomnia

Source: ClinicalTrials.gov NCT00492232 ↗

Enrolled (actual)

205

Serious AEs

0.8%

Results posted

Jul 2009

Primary outcomePrimary: Percentage of Participants Who Discontinued Zolpidem Therapy — 28.8; 32.7 Percentage of participants — p=0.484

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who Discontinued Zolpidem Therapy	28.8; 32.7	0.484
SECONDARY Change From Baseline in Weekly Zolpidem Dosage During Weeks 1-2	-11.8; -11.6	0.946
SECONDARY Change From Baseline in Weekly Zolpidem Dosage During Weeks 3-4	-35.3; -35.6	0.901
SECONDARY Change From Baseline in Weekly Zolpidem Dosage During Weeks 5-6	-40.2; -42.1	0.538
SECONDARY Change From Baseline in Weekly Zolpidem Dosage During Weeks 7-8	-52.1; -49.9	0.517
SECONDARY Change From Baseline in Weekly Zolpidem Dosage During Weeks 9-10	-60.6; -60.7	0.965
SECONDARY Change From Baseline in Weekly Zolpidem Frequency During Weeks 1-2	0.13; 0.04	0.617
SECONDARY Change From Baseline in Weekly Zolpidem Frequency During Weeks 3-4	-0.08; -0.26	0.541
SECONDARY Change From Baseline in Weekly Zolpidem Frequency During Weeks 5-6	-0.05; -0.60	0.163
SECONDARY Change From Baseline in Weekly Zolpidem Frequency During Weeks 7-8	-1.10; -1.24	0.757
SECONDARY Change From Baseline in Weekly Zolpidem Frequency During Weeks 9-10	-2.22; -2.34	0.820
SECONDARY Participants Who Completely Discontinued Zolpidem at the End of Double-Blind Treatment Period, by Method of Discontinuation	12; 8; 3; 8	—
SECONDARY Participants Who Achieved a 50% Reduction in Zolpidem Dosage at the End of the Double-Blind Treatment Period	48; 42	0.284
SECONDARY Participants Who Achieved a 50% Reduction in Zolpidem Dosage at Any Time During the Double-Blind Treatment Period	50; 50	0.389

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00492232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.