Generic equivalent of Ramelteon, Rozerem
3 SKUs available · Available to order · NABP accredited · DSCSA compliant
Ramelteon is the generic equivalent of the brand-name drug Ramelteon, Rozerem. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Ramelteon through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)]. Ramelteon tablet is indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1)
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections: Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.1)] Abnormal thinking, behavior changes, and complex behaviors [see Warnings and Precautions (5.3)] CNS effects [see Warnings and Precautions (5.4)] Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia. (6.1) To report SU…
7 DRUG INTERACTIONS Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon. (7.1) Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon; administer with caution. (7.1) Fluconazole (strong CYP2C9 inhibitor): Increases systemic exposure of ramelteon; administer with caution. (7.1) Donepezil: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with donepezil. (7.1) Doxepin: Increases systemic exp…
2 DOSAGE AND ADMINISTRATION Adult dose: 8 mg taken within 30 minutes of going to bed. (2.1) Should not be taken with or immediately after a high-fat meal. (2.1) Total daily dose should not exceed 8 mg. (2.1) 2.1 Dosage in Adults The recommended dose of ramelteon tablet is 8 mg taken within 30 minutes of going to bed. It is recommended that ramelteon tablets not be taken with or immediately after a high-fat meal. The total ramelteon tablet dose should not exceed 8 mg per day. 2.2 Dosing in Patien…
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with ramelteon. Describe the relevant signs/symptoms and advise seeking immediate medical attention if any such things occur. Sleep-Driving and other Complex Behaviors There have been reports of people getting out of bed after taking a sleep medication and driving their cars while not fully awake, often with no memory of the event. If a patient experie…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| RAMELTEON 8MG 30TAB Micro Labs Limited | 2-Day |
| RAMELTEON 8MG 30TABS | 2-Day |
| ROZEREM 8MG TAB 30 | 2-Day |
Premier Pharma stocks 3 Ramelteon SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Ramelteon is the generic equivalent of Ramelteon. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Ramelteon in 8 mg/1 and TABLET, TABLET, FILM COATED. Available from manufacturers including Micro Labs Limited.
Ramelteon carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
Create a free Premier Pharma account to unlock live wholesale pricing, place orders, and track shipments — approval typically takes minutes for licensed pharmacies, clinics, doctor's offices, and veterinary practices.