Trazodone

Therapeutic Class
 Antidepressant, Serotonin Reuptake Inhibitor/Antagonist
Indications

Treatment of major depressive disorder, Potential augmenting agent for antidepressants, hypnotic
Adult Doses

Depression
Adult: Oral:  Initially, 150 mg daily increased by 50-mg increments every 3-4 days up to 300-400 mg daily if necessary. Daily dosage may be given in divided doses or as a single dose at night. Max: 600 mg daily in divided doses in severely depressed patients. 
Extended release formulation: Initial: 150 mg once daily at bedtime (may increase by 75 mg/day every 3 days); maximum dose: 375 mg/day; once adequate response obtained, gradually reduce with adjustment based on therapeutic response
Elderly: Oral: Initially, 100 mg daily up to 300 mg daily. Daily dosage may be given in divided doses or as a single dose at night. 

Note: Therapeutic effects may take up to 6 weeks. Therapy is normally maintained for 6-12 months after optimum response is reached to prevent recurrence of depression.

Anxiety
Oral: Initially, 75 mg daily increased to 300 mg daily if necessary. Daily dosage may be given in divided doses or as a single dose at night.

Sedation/hypnotic (unlabeled use): Oral: 25-50 mg at bedtime (often in combination with daytime SSRIs). May increase up to 200 mg at bedtime. 
Pediatric Doses

Depression (unlabeled use):

Children 6-12 years: Initial: 1.5-2 mg/kg/day in divided doses; increase gradually every 3-4 days as needed; maximum: 6 mg/kg/day in 3 divided doses

Adolescents: Initial: 25-50 mg/day; increase to 100-150 mg/day in divided doses
Doses in Renal impairment

Severe: use with caution. 
Doses in Hepatic impairment

Severe: use with caution.
Contraindications

Immediate recovery phase post MI, porphyria. Pregnancy.
Boxed Warning

Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18-24 years of age) with major depressive disorder (MDD) and other psychiatric disorders.
Warnings / Precautions

Cardiovascular disorders, epilepsy, severe hepatic or renal insufficiency. Lactation. Monitor closely during initial therapy for signs of suicide. Discontinue if signs of hepatic dysfunction, blood dyscrasias or prolonged erection. Withdraw gradually. May impair ability to drive or operate machinery.
Adverse Reactions

Drowsiness, dizziness, restlessness, confusional state, headache, nausea, vomiting, weakness, weight loss, dry mouth, constipation, diarrhoea, tremor, bradycardia or tachycardia, orthostatic hypotension, oedema, blurred vision, priapism, skin rash, syndrome of inappropriate secretion of antidiuretic hormone.
Potentially Fatal: Blood dyscrasias, hepatocellular damage, neuroleptic maglignant syndrome.
Overdose Reactions

Symptoms: drowsiness, dizziness, vomiting, priapism, respiratory arrest, convulsions and changes in ECG . Management: Gastric lavage may be considered in life-threatening cases. Activated charcoal may also be used if used within 1 hr (in adults who have taken more than 1 g or children more than 150 mg). Treatment is symptomatic and supportive. Haemodialysis is unlikely to be useful.
Drug Interactions

May diminish action of some antihypertensives (e.g. clonidine). Increased trazodone concentrations with potent CYP3A4 inhibitors such as azole antifungals, HIV-protease inhibitors and macrolides. Reduced trazodone concentrations with CYP3A4 inducers such as carbamazepine. Increased risk of excessive hypotension and hepatotoxicity with phenothiazines. Decreased anticoagulant effect of warfarin. Increased digoxin or phenytoin levels with trazodone. Increased risk of neurotoxicity, serotonin syndrome with lithium. Sedative effect enhanced by alcohol and other CNS depressants (sedatives, hypnotics, antihistamines, opioid analgesics).
Potentially Fatal: Dangerous combination with MAOIs. Trazodone should not be given within 2 wk of discontinuing MAOIs and MAOIs should not be started within 1 wk of discontinuing trazodone.
See Below for More trazodone hydrochloride Drug Interactions
Food Interactions

Ethanol: May increase CNS depression; monitor for increased effects with coadministration. Caution patients about effects.

Food: Time to peak serum levels may be increased if immediate release trazodone is taken with food.

Herb/Nutraceutical: Avoid valerian, St John's wort, SAMe, kava kava (may increase risk of serotonin syndrome and/or excessive sedation)
Mechanism of Actions

Trazodone is a triazolopyridine antidepressant which selectively inhibits serotonin re-uptake at presynaptic neurons. Unlike TCAs, peripheral re-uptake of noradrenaline is not affected. It does not have very significant antimuscarinic properties but has a marked sedative action.
Metabolism

Substrate of CYP2D6 (minor), 3A4 (major); Inhibits CYP3A4 (weak); Induces P-glycoprotein
Pharmacodynamics

Therapeutic: 0.5-2.5 mcg/mL

Potentially toxic: >2.5 mcg/mL

Toxic: >4 mcg/mL

Onset of action: Therapeutic (antidepressant): Up to 6 weeks; sleep aid: 1-3 hours

Absorption: Well absorbed; Extended release: Cmax increases ~86% when taken shortly after ingestion of a high-fat meal compared to fasting conditions

Protein binding: 85% to 95%

Metabolism: Hepatic via CYP3A4 (extensive) to an active metabolite (mCPP)

Half-life elimination: 7-10 hours

Time to peak, serum:

Immediate release: 30-100 minutes; delayed with food (up to 2.5 hours)

Extended release: 9 hours; not significantly affected by food

Excretion: Primarily urine (<1% excreted unchanged); secondarily feces
Monitoring

Suicide ideation (especially at the beginning of therapy or when doses are increased or decreased)
Administration

Immediate release tablet: Dosing after meals may decrease lightheadedness and postural hypotension

Extended release tablet: Take on an empty stomach; swallow whole or as a half tablet without food.
Pregnancy Category

C: Drug Pregnancy Category Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation

Enters breast milk/use caution.
Storage Conditions

Oral: Store below 30°C.
ATC Classification
 N06AX05 - trazodone ; Belongs to the class of other antidepressants.
GenericPedia Classification
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    		•
    Storage

    Oral: Store below 30°C.
    Available As
  • Trazodone 100 mg
  • Trazodone 25 mg
  • Trazodone 50 mg

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