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Rozerem (Ramelteon) - Summary



ROZEREM (ramelteon) is an orally active hypnotic.

ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
See all Rozerem indications & dosage >>


Media Articles Related to Rozerem (Ramelteon)

Kessler researchers find ramelteon may be useful for sleep problems after TBI
Source: Rehabilitation / Physical Therapy News From Medical News Today [2015.08.21]
Pilot study showed longer total sleep time and improved cognition after 3 weeks of ramelteon therapyKessler researchers found preliminary evidence for the effectiveness of ramelteon for the...

'Start high and go low' dosing strategy advised for chronic insomnia
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2015.08.06]
A study finds chronic insomnia patients may get better treatment response and lower incidence of side effects if they use smaller and fewer doses of sleep drugs plus placebos.

Chronic insomnia sufferers may find relief with half of standard pill dose
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2015.08.04]
Findings point to use of placebos to help sufferers sleepThe roughly nine million Americans who rely on prescription sleeping pills to treat chronic insomnia may be able to get relief from as...

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...

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.

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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.

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Clinical Trials Related to Rozerem (Ramelteon)

Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia. [Active, not 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.

Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease [Terminated]
Patients with Parkinson's disease represent a significant proportion of VA elderly patients. Sleep disturbances and caregiver burnout association with this condition represent a significant problem. In this study, the investigators propose to perform an evaluation of a fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease. The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinson's disease while indirectly improving the quality of life for the patients and caregivers. The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture.

A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches [Terminated]
To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.

A Safety and Efficacy Study of Ramelteon Tablets for Sublingual Administration (TAK-375SL) in the Maintenance Treatment of Bipolar 1 Disorder [Withdrawn]

Safety and Efficacy of Ramelteon in Healthy Subjects [Completed]

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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: 2015-08-21

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