SONORX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SONORX (SONORX).

How it works

SONORX is a selective serotonin reuptake inhibitor (SSRI) that potentiates serotonergic activity in the CNS by blocking the reuptake of serotonin into presynaptic neurons.

What the body does with it

Metabolism	Primarily hepatic via CYP2D6 and CYP3A4; active metabolite N-desmethylsertraline; half-life approximately 26 hours.
Excretion	Renal: 70% (30% unchanged, 40% as metabolites); Biliary/fecal: 20% (via CYP3A4 metabolites); Other: 10% (e.g., sweat, exhalation).
Half-life	Terminal elimination half-life: 12 hours (range 10-14 hours); in severe renal impairment (CrCl <30 mL/min) extends to 24 hours.
Protein binding	88% bound to albumin; minor binding to α1-acid glycoprotein.
Volume of Distribution	1.2 L/kg (0.9-1.5 L/kg); indicates extensive tissue distribution.
Bioavailability	Oral: 75% (60-85%); Subcutaneous: 90%; Intramuscular: 85%; Rectal: 50% (40-60%).
Onset of Action	Oral: 30-45 minutes; Intravenous: 5-10 minutes; Subcutaneous: 15-20 minutes.
Duration of Action	Oral/IV: 6-8 hours (analgesic effect); sustained-release oral: 12 hours.

Classification & Brands

Dosing & administration

500 mg orally twice daily

Dosage form	SUSPENSION
Renal impairment	GFR > 60 mL/min: no adjustment; GFR 30-60 mL/min: 250 mg twice daily; GFR < 30 mL/min: 250 mg once daily; dialysis not studied
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 250 mg once daily; Child-Pugh C: not recommended
Pediatric use	> 12 years: 500 mg twice daily; < 12 years: not established
Geriatric use	No specific adjustment; monitor renal function and reduce dose per renal guidelines

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SONORX (SONORX).

Breastfeeding	Excreted in human milk; M/P ratio not determined. Potential for severe adverse effects in nursing infants including renal toxicity and hypokalemia. Contraindicated during breastfeeding.
Teratogenic Risk	First trimester: Increased risk of major congenital malformations, particularly neural tube defects and cardiac anomalies. Second and third trimesters: Risk of oligohydramnios, fetal renal impairment, and premature closure of ductus arteriosus. Overall FDA Category X.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with MAOIs or within 14 days of discontinuation; known hypersensitivity to SONORX; concurrent pimozide use.

Clinical Precautions

Precautions

Serotonin syndrome, activation of mania/hypomania, seizures, angle-closure glaucoma, hyponatremia, increased bleeding risk, and discontinuation syndrome.

Clinical Tips & Counseling

Drug interactions

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SONORX

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SONORX (SONORX).

How it works

SONORX is a selective serotonin reuptake inhibitor (SSRI) that potentiates serotonergic activity in the CNS by blocking the reuptake of serotonin into presynaptic neurons.

What the body does with it

Metabolism	Primarily hepatic via CYP2D6 and CYP3A4; active metabolite N-desmethylsertraline; half-life approximately 26 hours.
Excretion	Renal: 70% (30% unchanged, 40% as metabolites); Biliary/fecal: 20% (via CYP3A4 metabolites); Other: 10% (e.g., sweat, exhalation).
Half-life	Terminal elimination half-life: 12 hours (range 10-14 hours); in severe renal impairment (CrCl <30 mL/min) extends to 24 hours.
Protein binding	88% bound to albumin; minor binding to α1-acid glycoprotein.
Volume of Distribution	1.2 L/kg (0.9-1.5 L/kg); indicates extensive tissue distribution.
Bioavailability	Oral: 75% (60-85%); Subcutaneous: 90%; Intramuscular: 85%; Rectal: 50% (40-60%).
Onset of Action	Oral: 30-45 minutes; Intravenous: 5-10 minutes; Subcutaneous: 15-20 minutes.
Duration of Action	Oral/IV: 6-8 hours (analgesic effect); sustained-release oral: 12 hours.

Classification & Brands

Dosing & administration

500 mg orally twice daily

Dosage form	SUSPENSION
Renal impairment	GFR > 60 mL/min: no adjustment; GFR 30-60 mL/min: 250 mg twice daily; GFR < 30 mL/min: 250 mg once daily; dialysis not studied
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 250 mg once daily; Child-Pugh C: not recommended
Pediatric use	> 12 years: 500 mg twice daily; < 12 years: not established
Geriatric use	No specific adjustment; monitor renal function and reduce dose per renal guidelines

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SONORX (SONORX).

Breastfeeding	Excreted in human milk; M/P ratio not determined. Potential for severe adverse effects in nursing infants including renal toxicity and hypokalemia. Contraindicated during breastfeeding.
Teratogenic Risk	First trimester: Increased risk of major congenital malformations, particularly neural tube defects and cardiac anomalies. Second and third trimesters: Risk of oligohydramnios, fetal renal impairment, and premature closure of ductus arteriosus. Overall FDA Category X.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with MAOIs or within 14 days of discontinuation; known hypersensitivity to SONORX; concurrent pimozide use.

Clinical Precautions

Precautions

Serotonin syndrome, activation of mania/hypomania, seizures, angle-closure glaucoma, hyponatremia, increased bleeding risk, and discontinuation syndrome.

Clinical Tips & Counseling

Drug interactions

Loading safety data…