Sertraline

ATC code

N06AB06

Therapeutic class

Antidepressant (Selective Serotonin Reuptake Inhibitor) · Selective Serotonin Reuptake Inhibitor

Forms

film-coated tablet

Brand names

Besitran (ES) · Zoloft (US) · Lustral (UK)

Overall confidence

medium

Regulatory sources consulted

AEMPS CIMA FT 59718: https://cima.aemps.es/cima/dochtml/ft/59718/FT_59718.html
CredibleMeds.org QTdrugs List
Flockhart Table (Indiana University School of Medicine)
AEMPS CIMA · nº registro 59718 ↗
RxNorm rxcui 36437 ↗

Approved indications

Treatment of major depressive episodes. Prevention of recurrence of major depressive episodes.
Treatment of panic disorder, with or without agoraphobia.
Treatment of obsessive-compulsive disorder (OCD) in adults and pediatric patients aged 6-17 years.
Treatment of social anxiety disorder (social phobia).
Treatment of post-traumatic stress disorder (PTSD).

Contraindications

Absolute

Hypersensitivity to the active substance.
Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs).
Concomitant use of pimozide.

Clinical warnings

Boxed warning · Suicidal Thoughts and Behaviors: Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. — FDA
Major warning · Serotonin Syndrome: Potentially life-threatening. Risk increases with concomitant use of other serotonergic drugs. Symptoms include mental status changes, autonomic instability, and neuromuscular symptoms. — AEMPS CIMA

Drug interactions

HighMonoamine Oxidase Inhibitors (MAOIs)N06AF
Mechanism: Drastic increase in serotonin levels, risk of potentially fatal serotonin syndrome.
Recommendation: Contraindicated. A waiting period of at least 14 days is required between discontinuing an MAOI and starting sertraline, and vice versa.
AEMPS CIMA
HighPimozideN05AG02
Mechanism: Sertraline inhibits the metabolism of pimozide (via CYP2D6), increasing its concentrations and the risk of QT interval prolongation and ventricular arrhythmias.
Recommendation: Concomitant use is contraindicated.
AEMPS CIMA

Adverse events

Common (≥1%)

nausea · insomnia · dizziness · headache · diarrhea · dry mouth · fatigue · ejaculatory dysfunction

Rare but serious

serotonin syndrome · hyponatremia · QTc prolongation · abnormal bleeding · angle-closure glaucoma

Pregnancy and lactation

Pregnancy: Should not be used unless the woman's clinical condition requires it. Exposure during the third trimester may increase the risk of persistent pulmonary hypertension of the newborn (PPHN). Lactation: Passes into breast milk in small amounts; use should be evaluated considering the benefit to the mother versus the risk to the infant.