ramelteon (Rx)

Brand and Other Names:Rozerem
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 8mg

Insomnia

8 mg PO qHS

Safety and efficacy not established

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Interactions

Interaction Checker

and ramelteon

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Dizziness

            Somnolence (similar to placebo)

            Fatigue

            Headache

            Dysgeusia

            Nausea

            Frequency Not Defined

            Depression

            Worsening of insomnia

            Hallucinations

            Mania

            Angioedema (rare )

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            Warnings

            Contraindications

            Hypersensitivity

            Severe hepatic impairment

            Concomitant fluvoxamine

            Cautions

            Moderate hepatic impairment

            Concomitant CYP1A2 inhibitors

            Potential for cognitive & behavioral changes

            May impair ability to drive/perform hazardous tasks

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            Pregnancy & Lactation

            Pregnancy

            Available data from postmarketing reports with use in pregnant women have not identified drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Animal data

            • In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times recommended human dose (RHD) of 8 mg/day based on body surface area (mg/m2)

            Lactation

            There are no data regarding presence of drug or metabolites in human milk, effects on breastfed infant, or on milk production

            The drug and/or its metabolites are present in rat milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk; because of mechanism of action of drug, there is a potential risk for somnolence in a breastfed infant; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            Infants exposed to drug through breastmilk should be monitored for somnolence and feeding problems; a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 25 hours (approximately 5 elimination half-lives) after drug administration in order to minimize drug exposure to a breastfed infant

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Melatonin receptor agonist with high affinity for MT1 & MT2 receptors

            Absorption

            Absorption: 84%

            Bioavailability: 1.8%

            Distribution

            Protein bound: 82%

            Metabolism

            Extensive first-pass metabolism; mostly by hepatic CYP1A2

            Excretion

            Urine: 84%

            Feces: 4%

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            Administration

            Oral Administration

            Take within 30 min of going to bed

            Do not take with or immediately after high fat meal

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.