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Rozerem (Ramelteon) - Summary

 
 



ROZEREM SUMMARY

ROZEREM™ (ramelteon) is an orally active hypnotic chemically designated as (S)- N -[2-(1,6,7,8-tetrahydro-2 H -indeno-[5,4- b ]furan-8-yl)ethyl]propionamide and containing one chiral center.

ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.


See all Rozerem indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Rozerem (Ramelteon)

Talk Therapy May Help Ease Insomnia, Even With Other Health Woes
Source: MedicineNet Sleep Specialty [2015.07.17]
Title: Talk Therapy May Help Ease Insomnia, Even With Other Health Woes
Category: Health News
Created: 7/17/2015 12:00:00 AM
Last Editorial Review: 7/17/2015 12:00:00 AM

Cognitive behavioral therapy for insomnia with psychiatric, medical conditions
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2015.07.06]
Cognitive behavioral therapy is a widely used nonpharmacologic treatment for insomnia disorders and an analysis of the medical literature suggests it also can work for patients whose insomnia is...

Insomnia leads to decreased empathy in health care workers
Source: Caregivers / Homecare News From Medical News Today [2015.06.10]
Study highlights the importance to evaluate and treat insomnia in health care workersA new study suggests that insomnia decreases empathy in health care workers and may lead to adverse clinical...

73% of insomniacs cured after 1-hour therapy session
Source: Complementary Medicine / Alternative Medicine News From Medical News Today [2015.06.02]
A simple one-hour therapy session has helped to cure 73% of people suffering from acute insomnia, according to a new study from Northumbria University.

Insomnia
Source: MedicineNet Creutzfeldt-Jakob Disease Specialty [2014.07.17]
Title: Insomnia
Category: Diseases and Conditions
Created: 6/6/2005 12:00:00 AM
Last Editorial Review: 7/17/2014 12:00:00 AM

more news >>

Published Studies Related to Rozerem (Ramelteon)

Ramelteon in the treatment of chronic insomnia: systematic review and meta-analysis. [2012]
in the treatment of chronic insomnia... CONCLUSION: The efficacy and safety of ramelteon are promising for the chronic

Next-day effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on highway driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects. [2011.10.01]
STUDY OBJECTIVES: To evaluate the next-morning residual effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects following bedtime dosing and a middle of the night awakening... CONCLUSIONS: Ramelteon (8 mg) and zopiclone (7.5 mg) significantly impaired driving performance, cognitive, memory, and psychomotor performance the morning following bedtime administration. In contrast to zopiclone, ramelteon produced no balance impairments. CLINICAL TRIAL IDENTIFIER: NCT00319215 (www.clinicaltrials.gov).

Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia. [2011.10]
OBJECTIVE: Few interventions have been successful to prevent or reverse the medical complications associated with antipsychotic agents in the schizophrenia population. In particular, no single agent can correct multiple metabolic abnormalities such as insulin resistance, hyperlipidemia, inflammation, obesity, and fat distribution. We now report a randomized placebo-controlled pilot study to examine the effects of ramelteon on obesity and metabolic disturbances among subjects with schizophrenia... CONCLUSIONS: Although ramelteon decreased cholesterol, treatment may have to be longer than 8 weeks and with a higher dose for maximal effect of ramelteon for body fat and lipid changes. Future studies are needed for patients with schizophrenia with a larger sample size to fully understand ramelteon's effects on abdominal adiposity and lipids.

Efficacy and safety of ramelteon in Japanese adults with chronic insomnia: a randomized, double-blind, placebo-controlled study. [2011.02]
This randomized, double-blind, placebo-controlled study assessed the efficacy and safety of ramelteon 4 and 8 mg in Japanese adults with chronic insomnia. A secondary objective was to evaluate efficacy and safety when doses were uptitrated from placebo, ramelteon 4 and 8 mg to 4, 8 and 16 mg, respectively...

Evaluation of subjective efficacy and safety of ramelteon in Japanese subjects with chronic insomnia. [2011.02]
OBJECTIVE: To assess patient-reported efficacy and safety of ramelteon in Japanese patients with chronic insomnia... CONCLUSIONS: In Japanese adults with chronic insomnia, ramelteon 8 mg significantly reduced patient-reported sleep latency, increased total sleep time and improved sleep quality after 1 week of treatment. Ramelteon was generally well tolerated with no rebound insomnia. Copyright (c) 2010 Elsevier B.V. All rights reserved.

more studies >>

Clinical Trials Related to Rozerem (Ramelteon)

A Study to Evaluate the Ability of Ramelteon to Alleviate the Insomnia Symptoms Associated With Eastward Bound Jet Lag in Healthy Adult Volunteers [Completed]
This is a study to evaluate the ability of ramelteon to alleviate the insomnia symptoms of eastbound jet lag in healthy adult volunteers. Subjects are screened in Hawaii, and then travel to the Eastern Time Zone for randomization to receive either ramelteon or a placebo during evaluation in a sleep laboratory.

A Study to Evaluate the Phase-Shifting Effects of Repeated Daily Dosing of TAK-375 in Healthy Subjects [Completed]
This was a Dose-Ranging Study to Evaluate TAK-375 at 1 mg, 2 mg, 4 mg, or 8 mg versus a placebo taken once daily for five days.

Treatment of Subjects With Mild to Moderate Alzheimer's Disease and Sleep Treatment of Subjects Who Have Mild to Moderate Alzheimer's Disease and Sleep Disturbance With Rozeremâ„¢ [Completed]
The purpose of the study is to determine if subjects with mild to moderate Alzheimer's Disease and sleep disturbance will benefit from treatment with Rozerem.

Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia. [Recruiting]
To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.

A Safety and Efficacy Study of TAK-375 in Adults With Chronic Insomnia [Completed]
This was a study to evaluate the efficacy and safety of 8 mg TAK-375, 16 mg of TAK-375 or a placebo taken once daily in adults with chronic insomina for 7 weeks.

more trials >>

Reports of Suspected Rozerem (Ramelteon) Side Effects

Hepatic Function Abnormal (5)Liver Disorder (5)Cardio-Respiratory Arrest (5)Depressed Level of Consciousness (5)Tremor (4)Jaundice (3)Pyrexia (3)Overdose (3)Dizziness (3)Pneumonia (3)more >>


Page last updated: 2015-07-17

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