Adult Dosing
Major depressive disorder
Immediate release
- Initial dose: 150 mg/day PO in divided doses; may increase by 50 mg/day q3-4 days
- Maximum dose: 400 mg/day (outpatients) and 600 mg/day (inpatients) in divided doses
Notes:- Immediate-release tablets should be taken shortly after a meal or light snack
Extended release
- Initial dose: 150 mg PO qd; may increase by 75 mg/day q3 days
- Maximum dose: 375 mg daily
Notes:- Extended-release tablets should be taken orally at the same time every day, in the late evening preferably at bedtime, on an empty stomach
- On achieving an adequate response, dosage may be gradually reduced with subsequent adjustment depending on patient’s therapeutic response and tolerance
- During discontinuation, gradually reduce the dose and monitor carefully for withdrawal symptoms
- Avoid therapy in patients treated with linezolid or IV methylene blue as it may increase risk of serotonin syndrome
- Do not crush or chew extended-release tablets in order to maintain its controlled-release properties
Insomnia [Non-FDA Approved]
Immediate release
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18–24) with MDD and other psychiatric disorders, but increase in the risk of suicidality with antidepressants in adults beyond 24 yrs of age has not been proven. Also, there was a reduction in risk of suicidality with antidepressants in adults aged 65 and older [US Black Box Warning]
- Patients treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of therapy, or at times of dose modifications [US Black Box Warning]
- Families and caregivers of patients who are on antidepressants for MDD or other indications (psychiatric and nonpsychiatric) should be cautioned to monitor patients daily for the emergence of agitation, irritability, unusual changes in behavior, anxiety, panic attacks, insomnia, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, as well as the emergence of suicidality and should be advised to report such symptoms promptly to health care providers [US Black Box Warning]
- Use smallest dosage consistent with good patient management in order to reduce the risk of overdose
- Life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with antidepressants alone and may occur with trazodone treatment, but particularly with concomitant use of other serotonergic drugs (including SSRIs, SNRIs and triptans) and with drugs that impair serotonin metabolism (including MAOIs), or with antipsychotics or other dopamine antagonists
- Serotonin syndrome may present with mental status changes (e.g., agitation, hallucinations, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea). This syndrome, in its most severe form, can represent neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes
- Discontinue trazodone and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, if the above reactions occur and institute supportive symptomatic treatment
- Trazodone should not be used within 14 days of an MAOI
- Concomitant use with serotonin precursors (such as tryptophan) is not recommended
- Concomitant treatment of trazodone with an SSRI, SNRI or a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted and careful observation of the patient is advised, particularly during treatment initiation and dose increases
- Before starting treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder
- Trazodone is known to prolong the QT/QTc interval, which can cause torsades de pointes with sudden, unexplained death. This condition has not been observed with the use of trazodone at recommended doses in pre-marketing trials; however, there have been post-marketing reports of this condition with the immediate-release form of trazodone (in the presence of multiple confounding factors), even at doses of 100 mg/day or less
- Concomitant use of drugs that prolong the QT interval or that are inhibitors of CYP3A4 may increase the risk of cardiac arrhythmia
- Hypotension, including orthostatic hypotension and syncope, has been reported in patients receiving trazodone. Concomitant use with an anti-hypertensive may require a reduction in the dose of anti-hypertensive drug
- Priapism (painful erections greater than 6 hours in duration) has been reported in males receiving this drug. This drug should be immediately discontinued in males with an erection lasting >6 hours (painful or not) and should be given emergency medical attention
- Hyponatremia may occur as a result of treatment with antidepressants; elderly patients and those taking diuretics or who are otherwise volume-depleted can be at greater risk of developing hyponatremia with antidepressants. Discontinue the drug in patients with symptomatic hyponatremia and institute appropriate medical intervention
- During discontinuation, reduce the dose gradually due to the risk of withdrawal symptoms such as anxiety, agitation and sleep disturbances
- Patients should be cautioned about potential risk of bleeding associated with the concomitant use of trazodone and aspirin, NSAIDs, or other drugs that affect coagulation or bleeding
- Trazodone may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous activities
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Cardiac disease
- Concomitant use of CNS depressants
- Bipolar disorder
- Alcohol use
- Conditions predisposing to priapism
- Geriatric patients
Supplemental Patient Information
- Advise family and caregivers of the patients to closely monitor patients due to the increased risk of suicidal thoughts especially in children, teenagers and young adults
- Advise patients to promptly report their physicians on occurrence of symptoms such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania and mania
- Caution patients about performing hazardous tasks such as driving automobiles or operating heavy machinery, until they are reasonably certain that the medication does not affect them
Pregnancy Category:C
Breastfeeding: Trazodone levels in milk are very low and would not be expected to cause any adverse effects in nursing infants, especially if the infant is older than 2 months or when doses of 100 mg or less are used at bedtime for sleep. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT) last accessed 22 Aug 2011). Manufacturer advises caution while administrating the drug to nursing women.
Pricing data from www.DrugStore.com in U.S.A.
- TraZODone HCl 50 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $11.99
90 mg = $33.98 - TraZODone HCl 150 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $20.87
90 mg = $62.61 - TraZODone HCl 300 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
100 mg = $402.2
300 mg = $1206.61 - Oleptro 150 MG TB24 [Bottle] (ANGELINI LABOPHARM)
30 mg = $109.99
90 mg = $299.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
