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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)

'Insomnia may increase the risk of stroke,' researchers say
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2014.04.04]
Individuals with insomnia are at a much higher risk of hospitalization from stroke than those without the sleep disorder, according to a new study from researchers in Taiwan.

Insomnia May Raise Stroke Risk, Especially for Younger Adults
Source: MedicineNet Sleep Specialty [2014.04.04]
Title: Insomnia May Raise Stroke Risk, Especially for Younger Adults
Category: Health News
Created: 4/3/2014 4:35:00 PM
Last Editorial Review: 4/4/2014 12:00:00 AM

Insomniacs' Brains May Work Differently
Source: MedicineNet Sleep Aids And Stimulants Specialty [2014.03.03]
Title: Insomniacs' Brains May Work Differently
Category: Health News
Created: 2/28/2014 4:35:00 PM
Last Editorial Review: 3/3/2014 12:00:00 AM

Insomnia Cure Boosts Success of Depression Treatment, Study Finds
Source: MedicineNet Sleep Aids And Stimulants Specialty [2013.11.20]
Title: Insomnia Cure Boosts Success of Depression Treatment, Study Finds
Category: Health News
Created: 11/19/2013 4:36:00 PM
Last Editorial Review: 11/20/2013 12:00:00 AM

Prescription Sleep Aids a Common Choice for American Insomnia
Source: MedicineNet temazepam Specialty [2013.08.29]
Title: Prescription Sleep Aids a Common Choice for American Insomnia
Category: Health News
Created: 8/29/2013 9:35:00 AM
Last Editorial Review: 8/29/2013 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: 2014-04-04

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