ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1, 6, 7, 8tetrahydro-2H-indeno-[5, 4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the.
Patients should avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking ROZEREM (ramelteon).
Included as part of the PRECAUTIONS section.
In addition, in vitro data indicate that ramelteon does not cause false-positive results for benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screening methods in vitro. ROZEREM (ramelteon) is not known to interfere with commonly used clinical laboratory tests.
Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11.
The AUC0-inf and Cmax of ramelteon increased by approximay 100% and 87%, respectively upon coadministration of donepezil with ROZEREM (ramelteon).
Find patient medical information for Rozerem Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
Keep all medicines away from children and pets. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Store at 77 degrees F (25 degrees C) away from light and moisture. Do not store in the bathroom. Keep container tightly closed.
Alcohol or marijuana can make you more dizzy or drowsy. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. This drug may make you dizzy or drowsy.
Rozerem is a hypnotic medicine used to treat insomnia is associated with having trouble falling asleep. Learn about side effects, interactions and indications.
Rozerem (ramelteon) is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle.".
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CSA Schedule Not a controlled drug.
This will make it harder for your body to absorb the medication. Avoid taking Rozerem together with or just after eating a high-fat meal.
a breathing disorder such as chronic obstructive pulmonary disease (COPD); or.
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Ramelteon, marketed as Rozerem among others, is a sleep agent that selectively binds to the MT1 and MT2 receptors in the suprachiasmatic nucleus (SCN), instead of binding to GABAA receptors, such as with drugs like zolpidem. It however does not appear to speed the onset of sleep or the amount of sleep a person gets.
Efficacy may be reduced when ramelteon is used in combination with potent CYP enzyme inducers such as rifampin, since ramelteon concentrations may be decreased.
The activity of ramelteon at the MT 1 and MT 2 receptors is believed to contribute to its sleep-promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle. Ramelteon also does not interfere with the activity of a number of selected enzymes in a standard panel.
ROZEREM (ramelteon) is approved for adults having trouble falling asleep from insomnia. Ask your doctor about ROZEREM. See Important Safety Information and Prescribing Information.
ROZEREM is approved for adults having trouble falling asleep from insomnia.
Worsening of depression, suicidal thoughts and completed suicides, hallucinations, and nightmares can occur with ROZEREM.
Do not drink alcohol or take other medicines that can make you sleepy when using ROZEREM.
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Please see Prescribing Information and Medication Guide for ROZEREM.
Call your healthcare provider if you have abnormal thoughts or behaviors, or your insomnia worsens or is not better within 7-10 days.