Trazodone

DRUG INFORMATION

  ADULT
    - Starting dose: 150 mg in divided doses daily.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'dosage and
      administration', retrieved 2026-08-29
    - May be increased by 50 mg per day every three to four days.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'dosage and
      administration', retrieved 2026-08-29
    - Maximum dose: 400 mg per day in divided doses ( 2 ).
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in the pediatric population have not been established.
      Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric
      patients [see Boxed Warning, Warnings and Precautions ( 5.1 )] .
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Serotonergic antidepressants have been associated with cases of clinically
      significant hyponatremia in elderly patients, who may be at greater risk for this
      adverse reaction [see Warnings and Precautions ( 5.11 )]. 8.6 Renal Impairment
      Trazodone has not been studied in patients with renal impairment.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Trazodone should be used with caution in this population. 8.7 Hepatic Impairment
      Trazodone has not been studied in patients with hepatic impairment.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to antidepressants during pregnancy.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'pregnancy',
      retrieved 2026-08-29
    - Trazodone hydrochloride has been shown to cause increased fetal resorption and
      other adverse effects on the fetus in the 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/m 2 basis.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'pregnancy',
      retrieved 2026-08-29
    - There was also an increase in congenital anomalies in the rabbit at approximately
      7.3 to 22 times the MRHD on a mg/m 2 basis (see Data) .
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Risk Summary Data from published literature report the transfer of trazodone into
      human milk.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - There are no data on the effect of trazodone on milk production.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - Limited data from postmarketing reports have not identified and association of
      adverse effects on the breastfed child.
      Source: US FDA label for trazodone (Trazodone Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29