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The following serious adverse reactions are discussed in greater detail in other sections:
- Severe anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
- Abnormal thinking, behavior changes, and complex behaviors [see WARNINGS AND PRECAUTIONS]
- CNS effects [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Adverse Reactions Resulting in Discontinuation of Treatment
The data described in this section reflect exposure to ROZEREM (ramelteon) in 5373 subjects, including 722 exposed for 6 months or longer, and 448 subjects for one year.
Six percent of the 5373 individual subjects exposed to ROZEREM (ramelteon) in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2279 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ROZEREM (ramelteon) were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less.
ROZEREM (ramelteon) Most Commonly Observed Adverse Events
Table 1 displays the incidence of adverse events reported by the 2861 patients with chronic insomnia who participated in placebo-controlled trials of ROZEREM (ramelteon) .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Table 1: Incidence (% of subjects) of Treatment-Emergent
|MedDRA Preferred Term||Placebo
|Ramelteon 8 mg
Read the Rozerem (ramelteon) Side Effects Center for a complete guide to possible side effects
Effects of Other Drugs on ROZEREM (ramelteon)
Fluvoxamine (strong CYP1A2 inhibitor)
AUC0-inf for ramelteon increased approximately 190-fold, and the Cmax increased approximately 70-fold upon coadministration of fluvoxamine and ROZEREM (ramelteon) , compared to ROZEREM (ramelteon) administered alone. ROZEREM (ramelteon) should not be used in combination with fluvoxamine [see CONTRAINDICATIONS, CLINICAL PHARMACOLOGY]. Other less strong CYP1A2 inhibitors have not been adequately studied. ROZEREM (ramelteon) should be administered with caution to patients taking less strong CYP1A2 inhibitors.
Rifampin (strong CYP enzyme inducer)
Administration of multiple doses of rifampin resulted in a mean decrease of approximately 80% in total exposure to ramelteon and metabolite M-II. Efficacy may be reduced when ROZEREM (ramelteon) is used in combination with strong CYP enzyme inducers such as rifampin [see CLINICAL PHARMACOLOGY].
Ketoconazole (strong CYP3A4 inhibitor)
The AUC0-inf and Cmax of ramelteon increased by approximately 84% and 36% upon coadministration of ketoconazole with ROZEREM (ramelteon) . ROZEREM (ramelteon) should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole [see CLINICAL PHARMACOLOGY].
Fluconazole (strong CYP2C9 inhibitor)
The AUC0-inf and Cmax of ramelteon was increased by approximately 150% when ROZEREM (ramelteon) was coadministered with fluconazole. ROZEREM (ramelteon) should be administered with caution in subjects taking strong CYP2C9 inhibitors such as fluconazole [see CLINICAL PHARMACOLOGY].
The AUC0-inf and Cmax of ramelteon increased by approximately 100% and 87%, respectively upon coadministration of donepezil with ROZEREM (ramelteon) . Patients should be closely monitored when ROZEREM (ramelteon) is coadministered with donepezil [see CLINICAL PHARMACOLOGY].
The AUC0-inf and Cmax of ramelteon increased by approximately 66% and 69%, respectively, upon coadministration of doxepin donepezil with ROZEREM (ramelteon) . Patients should be closely monitored when ROZEREM (ramelteon) is coadministered with doxepin [see CLINICAL PHARMACOLOGY].
Effect of Alcohol on ROZEREM (ramelteon)
Alcohol by itself impairs performance and can cause sleepiness. Since the intended effect of ROZEREM (ramelteon) is to promote sleep, patients should be cautioned not to consume alcohol when using ROZEREM [see CLINICAL PHARMACOLOGY]. Use of the products in combination may have an additive effect.
Drug/Laboratory Test Interactions
ROZEREM (ramelteon) is not known to interfere with commonly used clinical laboratory tests. 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 .
Drug Abuse And Dependence
ROZEREM (ramelteon) is not a controlled substance.
Discontinuation of ramelteon in animals or in humans after chronic administration did not produce withdrawal signs. Ramelteon does not appear to produce physical dependence.
A laboratory abuse potential study was performed with ROZEREM [see Clinical Studies].
Ramelteon did not produce any signals from animal behavioral studies indicating that the drug produces rewarding effects. Monkeys did not self-administer ramelteon and the drug did not induce a conditioned place preference in rats. There was no generalization between ramelteon and midazolam. Ramelteon did not affect rotorod performance, an indicator of disruption of motor function, and it did not potentiate the ability of diazepam to interfere with rotorod performance.
Read the Rozerem Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/14/2010
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