Rozerem
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly) [see Clinical Studies (14)].
History
There is currently no drug history available for this drug.
Other Information
ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-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 following chemical structure:
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.
Each ROZEREM tablet includes the following inactive ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black.
Sources
Rozerem Manufacturers
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Physicians Total Care, Inc.
![Rozerem (Ramelteon) Tablet, Film Coated [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Rozerem | Physicians Total Care, Inc.
2.1 Dosage in AdultsThe recommended dose of ROZEREM is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM not be taken with or immediately after a high-fat meal.
The total ROZEREM dose should not exceed 8 mg per day.
2.2 Dosing in Patients with Hepatic ImpairmentROZEREM is not recommended in patients with severe hepatic impairment. ROZEREM should be used with caution in patients with moderate hepatic impairment [see Warnings and Precautions (5.6), Clinical Pharmacology (12.4)].
2.3 Administration with Other MedicationsROZEREM should not be used in combination with fluvoxamine. ROZEREM should be used with caution in patients taking other CYP1A2 inhibiting drugs [see Drug Interactions (7), Clinical Pharmacology (12.5)].
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Takeda Pharmaceuticals America, Inc.
Rozerem | Takeda Pharmaceuticals America, Inc.
2.1 Dosage in AdultsThe recommended dose of ROZEREM is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM not be taken with or immediately after a high-fat meal.
The total ROZEREM dose should not exceed 8 mg per day.
2.2 Dosing in Patients with Hepatic ImpairmentROZEREM is not recommended in patients with severe hepatic impairment. ROZEREM should be used with caution in patients with moderate hepatic impairment [see Warnings and Precautions (5.6), Clinical Pharmacology (12.4)].
2.3 Administration with Other MedicationsROZEREM should not be used in combination with fluvoxamine. ROZEREM should be used with caution in patients taking other CYP1A2 inhibiting drugs [see Drug Interactions (7), Clinical Pharmacology (12.5)].
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Rebel Distributors Corp
Rozerem | Rebel Distributors Corp
2.1 Dosage in AdultsThe recommended dose of ROZEREM is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM not be taken with or immediately after a high-fat meal.
The total ROZEREM dose should not exceed 8 mg per day.
2.2 Dosing in Patients with Hepatic ImpairmentROZEREM is not recommended in patients with severe hepatic impairment. ROZEREM should be used with caution in patients with moderate hepatic impairment [see Warnings and Precautions (5.6), Clinical Pharmacology (12.4)].
2.3 Administration with Other MedicationsROZEREM should not be used in combination with fluvoxamine. ROZEREM should be used with caution in patients taking other CYP1A2 inhibiting drugs [see Drug Interactions (7), Clinical Pharmacology (12.5)].
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Lake Erie Medical Dba Quality Care Products Llc
Rozerem | Lake Erie Medical Dba Quality Care Products Llc
2.1 Dosage in AdultsThe recommended dose of ROZEREM is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM not be taken with or immediately after a high-fat meal.
The total ROZEREM dose should not exceed 8 mg per day.
2.2 Dosing in Patients with Hepatic ImpairmentROZEREM is not recommended in patients with severe hepatic impairment. ROZEREM should be used with caution in patients with moderate hepatic impairment [see Warnings and Precautions (5.6), Clinical Pharmacology (12.4)].
2.3 Administration with Other MedicationsROZEREM should not be used in combination with fluvoxamine. ROZEREM should be used with caution in patients taking other CYP1A2 inhibiting drugs [see Drug Interactions (7), Clinical Pharmacology (12.5)].
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Bryant Ranch Prepack
Rozerem | Bryant Ranch Prepack
2.1 Dosage in AdultsThe recommended dose of ROZEREM is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM not be taken with or immediately after a high-fat meal.
The total ROZEREM dose should not exceed 8 mg per day.
2.2 Dosing in Patients with Hepatic ImpairmentROZEREM is not recommended in patients with severe hepatic impairment. ROZEREM should be used with caution in patients with moderate hepatic impairment [see Warnings and Precautions (5.6), Clinical Pharmacology (12.4)].
2.3 Administration with Other MedicationsROZEREM should not be used in combination with fluvoxamine. ROZEREM should be used with caution in patients taking other CYP1A2 inhibiting drugs [see Drug Interactions (7), Clinical Pharmacology (12.5)].
![Rozerem (Ramelteon) Tablet, Film Coated [Takeda Pharmaceuticals America, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9de82310-70e8-47b9-b1fc-6c6848b99455&name=rozerem-02.jpg)
![Rozerem (Ramelteon) Tablet, Film Coated [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3740dcc6-9ee8-4187-9112-632050043240&name=3740dcc6-9ee8-4187-9112-632050043240-02.jpg)
![Rozerem Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b6fe9db3-cf46-4b2b-a097-9c96f9c30908&name=rozerem8mg30takeda.jpg)
![Rozerem (Ramelteon) Tablet, Film Coated [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3fb00527-db09-4c9b-8388-71a891455d65&name=33891.jpg)
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