trazodone (Rx)

Brand and Other Names:Desyrel, Desyrel Dividose, more...Oleptro, Trazodone D
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 50mg
  • 100mg
  • 150mg
  • 300mg

tablet, extended-release

  • 150mg
  • 300mg
more...

Depression

Initial 150 mg/day PO divided q8-12hr

Increase by 50 mg/day q3-7Days

Outpatient: No more than 400 mg/day

Inpatient: No more than 600 mg/day

Oleptro (extended-release)

  • 150 mg PO HS initially; may increase by increments of 75 mg/day q3Days; not to exceed 375 mg/day
  • Swallow whole or may break in half along scored line; do not chew or crush

Insomnia (Off-label)

50-100 mg PO qDay

Aggressive Behavior (Off-label)

Initial: 50 mg PO q12hr

Maintenance: 75-400 mg/day divided PO q6-12hr

Cocaine Withdrawal (Off-label)

150-200 mg PO qDay

Alcohol Withdrawal (Off-label)

100-600 mg/day divided PO

Insomnia (Off-label)

25-100 mg PO qHS

Prevention of Migraine (Off-label)

100 mg PO qDay

Dose considerations

MAO inhibitors: Do not administer trazodone within 14 days of administering a MAO inhibitor when treating a psychiatric disorder

Coadministration with MAO inhibitors linezolid or IV methylene blue: Trazodone not recommended in patients actively receiving linezolid or IV methylene blue; consider other interventions if treating psychiatric condition; if coadministration necessary, because benefits outweigh risks, monitor for serotonin syndrome for 2 weeks or until 24 hr after last dose of linezolid or IV methylene blue, whichever comes first; may resume trazodone 24 hr after last dose of linezolid or IV methylene blue

Dosage Forms & Strengths

tablet

  • 50mg
  • 100mg
  • 150mg
  • 300mg

tablet, extended-release

  • 150mg
  • 300mg
more...

Depression (Off-label)

<6 years: Safety and efficacy not established

6-12 years: 1.5-2 mg/kg/day PO in divided doses initially; not to exceed 6 mg/kg/day divded q8hr 

>12 years: 25-50 mg/day PO; increase by 100-150 mg in divided doses

See Black Box Warning

Dravet Syndrome (Orphan)

Orphan designation for treatment of Dravet syndrome

Sponsor

  • Epygenix Therapeutics, Inc; 140 E. Ridgewood Avenue, Suite 415 South Tower; Paramus, New Jersey 07652

Depression

Immediate release: 25-50 mgPO qHS; increase dose by 25-50 mg every three days if inpatient or every week if oupatient not to exceed 75-150 mg/day

Extended release: Experience limited; use 150 mg PO HS initially; may increase by increments of 75 mg/day q3Days; not to exceed 375 mg/day

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Interactions

Interaction Checker

and trazodone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Blurred vision (5-15%)

            Dizziness (20-28%)

            Drowsiness (24-40%)

            Dry mouth (15-34%)

            Fatigue (6-15%)

            Headache (10-33%)

            Nausea/vomiting (10-21%)

            1-10%

            Constipation (7-8%)

            Edema (3-7%)

            Confusion (5-6%)

            Disorientation (<2%)

            Incoordination (2-5%)

            Nasal congestion (3-6%)

            Orthostatic hypotension (<7%)

            Syncope (<5%)

            Tremor (1-5%)

            Weight change (5%)

            Ejaculation disorder (2%)

            Decreased libido (1-2%)

            <1%

            Priapism

            Sedation

            Alopecia

            Anxiety

            Acne

            Anemia

            Increased apetite

            Diplopia

            Insomnia

            Urinary retention

            Vertigo

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            Warnings

            Black Box Warnings

            In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 yr of age) taking antidepressants for major depressive disorders and other psychiatric illnesses

            This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years

            In children and young adults, risks must be weighed against the benefits of taking antidepressants

            Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments

            The patient’s family should communicate any abrupt changes in behavior to the healthcare provider

            Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy

            This drug is not FDA approved for use in pediatric patients or for treatment of bipolar depression

            Contraindications

            Hypersensitivity

            Coadministration with serotonergic drugs

            • Risk of serotonin syndrome when coadministered within 14 days of MAOIs, or coadministered with other strong serotonergic drugs (eg, SNRIs, SSRIs)
            • Starting trazodone in a patient who is being treated with linezolid or IV methylene blue is contraindicated because of an increased risk of serotonin syndrome
            • If linezolid or IV methylene blue must be administered, discontinue trazodone immediately and monitor for CNS toxicity; may resume clomipramine 24 hr after last linezolid or methylene blue dose or after 2 weeks of monitoring, whichever comes first

            Cautions

            Administer shortly after meal; if drowsiness occurs, decrease dosage or give most of divided dosage HS

            Discontinue if prolonged or inappropriate erection occurs

            Discontinue if neutropenia, leukopenia

            Use caution in patients with risk of seizures

            Clinical worsening and suicide ideation may occur despite medication in adolescents and young adults (18-24 years)

            Perform leukocyte and differential with fever, sore throat, or other signs of infection

            Discontinue if leukocytes/ANC decreases below normal range

            Coadministration with MAO inhibitors: risk of serotonin syndrome

            Drugs that interfere with serotonin reuptake have been associated with bleeding; trazodone may also impair platelet aggregation resulting in increased risk of bleeding events

            Potentially life-threatening serotonin syndrome reported when coadministered with drugs that impair serotonin metabolism (in particular, MAOIs, including nonpsychiatric MAOIs, such as linezolid and IV methylene blue) (see Contraindications)

            Coadministration with NSAIDs and aspirin, may increase risk of bleeding

            Bone fractures associated with antidepressant treatments

            Increases risk of hyponatremia

            Use caution in patients with risk of seizures including head trauma, alcoholism, brain damage

            May worsen psychosis in patients or precipitate mania or hypomania; screen, for bipolar disorder, patients presenting with depressive symptoms

            May cause orthostatic hypotension and syncope; use wiht caution

            QT prolongation with or without torsade de pointes and ventricular tachycardia reported

            May increase risk associated with electroconvulsive therapy (ECT); discontinue ECT before initiating trazodone therapy

            Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy

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            Pregnancy & Lactation

            Pregnancy

            Published prospective cohort studies, case series, and case reports over several decades with use in pregnant women have not identified drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Drug has been shown to cause increased fetal resorption and other adverse effects on fetus in rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m² basis; there was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the MRHD on a mg/m² basis

            Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum

            Lactation

            Data from published literature report the transfer of trazodone into human milk; there are no data on effect on milk production; limited data from postmarketing reports have not identified an association of adverse effects on breastfed child

            The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child or from underlying maternal condition

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Antidepressant structurally unrelated to SSRIs, tricyclics, tetracyclics or MAOIs, but also inhibits neuronal uptake of serotonin (but not NE); it is a histamine and alpha1-adrenergic receptor antagonist; causes adrenoceptor subsensitivity

            Absorption

            Almost completely absorbed (increased by food)

            Onset: 6 weeks (antidepressant); 1-3 hr sleep aid

            Peak serum time: 30-100 min (up to 2.5 hr if taken with food); 9 hr (extended release)

            Concentration: 480-1620 ng/mL (dose-dependent)

            Distribution

            Protein bound: 85-95%

            Metabolism

            Metabolism: hepatic P450 enzyme CYP2D6

            Metabolites: l-m-chlorophenylpiperazine

            Elimination

            Half-life: 7-10 hr

            Excretion: Urine (75%); feces (25%)

            Dialyzable: No

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            Administration

            Oral Administration

            Take with food

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            Images

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            Formulary

            FormularyPatient Discounts

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            • View the formulary and any restrictions for each plan.
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            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.