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Zoloft

(sertraline)

Zoloft (sertraline); not controlled

Full Prescribing Information DailyMed Drug Information

Summary

Zoloft is a selective serotonin reuptake inhibitor supplied as a scored tablet and an oral concentrate, with one pediatric indication: obsessive-compulsive disorder from 6 years of age. Response is judged over weeks of continuous dosing. Its short half-life reaches steady state within a week, which is why it titrates fast and why it must be tapered. Not controlled; brand and generic.

Forms & Strengths

  • Tablets, film coated, scored: 25 mg, 50 mg, 100 mg
  • Oral solution (concentrate, 12% alcohol): 20 mg/mL
  • Capsules: 150 mg, 200 mg. Separate label; maintenance only

Dosing

  • Age:
    • OCD: 6 y/o and older. The only pediatric indication
    • MDD, panic, PTSD, social anxiety: adults only; PMDD: adult women
  • Onset: 2 to 3 weeks for early effect; 12 weeks for full response in OCD
  • Duration: continuous with once-daily dosing
  • Initial Dose:
    • Pediatric OCD, 6 to 12 y/o: 25 mg daily
    • Pediatric OCD, 13 to 17 y/o: 50 mg daily
    • Adults: 50 mg daily; 25 mg for panic, PTSD and social anxiety
  • Titration:
    • 25 to 50 mg/day increments at intervals of no less than 1 week
    • Therapeutic range 50 to 200 mg/day; halve both in mild hepatic impairment
  • Max Dose:
    • 200 mg/day at any age from 6 years; 100 mg/day in mild hepatic impairment
    • Moderate or severe hepatic impairment: not recommended
  • Considerations: Do not initiate or titrate with the 150 mg or 200 mg capsules; their own label forbids it. Screen for bipolar history first; taper when stopping.

Pharmacology

  • Mechanism: Inhibits serotonin reuptake at SERT with very weak effect on norepinephrine and dopamine, and an unusually clean receptor panel
  • Delivery / Release: immediate-release tablet or concentrate, approximately bioequivalent; food is no constraint
  • Metabolism: first-pass N-demethylation to the less active N-desmethylsertraline. Half-life about 26 hours, steady state in one week. Mild hepatic impairment triples exposure
  • Class Positioning: steady state in a week against fluoxetine's 4 to 5 weeks, so it titrates weekly, at the cost of a discontinuation syndrome Prozac lacks

Indications

  • Obsessive-Compulsive Disorder (ICD-10: F42.x): 6 y/o and older. The only pediatric indication
  • Major Depressive Disorder (ICD-10: F32.x, F33.x): adults only
  • Panic Disorder, PTSD, Social Anxiety Disorder (ICD-10: F41.0, F43.1, F40.10): adults only
  • Premenstrual Dysphoric Disorder (ICD-10: N94.3): adult women only

Off-Label Uses

  • Pediatric anxiety disorders (ICD-10: F41.1, F40.10, F93.0): sertraline with CBT beat either alone; CBT alone beat sertraline alone for remission (AHRQ 2017). On-label option: Cymbalta from 7 y/o
  • Pediatric major depressive disorder (ICD-10: F32.x): two trials did not support an indication. Prozac carries that one
  • Pediatric PTSD (ICD-10: F43.1): insufficient, despite the adult indication
  • Anxiety and irritability in autism (ICD-10: F84.0): insufficient; a trial in children 24 to 72 months found no difference (Potter 2019)

Contraindications & Warnings

  • Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS in children, adolescents and young adults.
    • Monitor closely for clinical worsening and emergent suicidality in the initial few months and at every dose change, up or down.
    • Counsel family members to watch for behaviour change and alert the prescriber.
  • Contraindicated:
    • An MAOI concurrently or within 14 days either way, including linezolid and methylene blue, because of serotonin syndrome.
    • Pimozide; and known hypersensitivity, including anaphylaxis and angioedema.
    • ORAL SOLUTION ONLY: concurrent disulfiram, because of its 12% alcohol.
  • Use with caution:
    • Seizure disorder, unstudied; those patients were excluded from the trials.
    • Untreated narrow angles: the label says AVOID; pupillary dilation can trigger angle closure.
    • QTc risk factors; mild hepatic impairment, halving both dose and ceiling.
    • NSAIDs, aspirin or anticoagulants; diuretics; bipolar disorder or family history.
  • Screen before starting:
    • Personal or family history of bipolar disorder; the label makes this a numbered dosing step.
    • Baseline height, weight, sexual function and QTc risk; disulfiram if using the solution.

Drug Interactions

  • MAOIs (selegiline, phenelzine, linezolid, methylene blue): contraindicated. 14 days in both directions, unlike fluoxetine's 5-week exit
  • CYP2D6 substrates, atomoxetine named by the label (Strattera, propafenone, metoprolol): sertraline raises substrate exposure.
    • Decrease the substrate dose if needed; raise it again once sertraline stops.
    • For atomoxetine, lengthen the titration interval to 4 weeks. This pair, and Qelbree, stack two pediatric suicidality boxed warnings.
  • Bupropion (Wellbutrin XL): doubles 2D6 inhibition and stacks seizure cautions
  • Other serotonergic drugs (SSRIs, SNRIs, triptans, TCAs, opioids, lithium, AMPHETAMINES): serotonin syndrome. Stop all for agitation, hyperthermia, rigidity or myoclonus
  • Phenytoin: check the level when sertraline starts and at each titration step
  • Antiplatelets and anticoagulants (aspirin, warfarin, NSAIDs): bleeding; monitor the INR
  • QTc-prolonging drugs (ziprasidone, erythromycin, amiodarone): avoid, or obtain an ECG before each increase

Administration

  • Give once daily, morning or evening, with or without food; fix the time and keep it fixed.
  • Tablets are scored at every strength, so a 12.5 mg half-step needs no liquid.
  • Oral solution: use the SUPPLIED dropper, graduated at 25 mg and 50 mg only. Dilute in 4 ounces of water, ginger ale, lemonade or orange juice ONLY, and drink immediately.
  • Do not start or titrate with the 150 mg or 200 mg capsules; their label says do not initiate treatment with them.
  • Missed dose: take it the same day; do not double up.
  • Switching to or from an MAOI: allow 14 days in either direction.

Side Effects

  • Common: nausea, insomnia, diarrhea, dry mouth, fatigue, dizziness, somnolence, tremor, agitation, decreased appetite, hyperhidrosis.
    • Pediatric trials add fever, hyperkinesia, urinary incontinence, aggression, epistaxis and purpura.
  • Serious:
    • Suicidal thoughts and behavior: the boxed warning. Change or stop the regimen if suicidality emerges.
    • Serotonin syndrome: stop every serotonergic agent immediately and treat supportively.
    • Discontinuation syndrome, which on this label explicitly includes SEIZURES. Do not stop abruptly.
    • Mania or hypomania, in 0.4%. Stop and reassess the diagnosis.
    • Hyponatremia and SIADH; QTc prolongation and torsades; bleeding.
    • Weight loss: about 1 kg against placebo; 7% of children aged 6 to 11 lost over 7% of body weight.
    • Angle-closure glaucoma; sexual dysfunction.

Monitoring & Labs

  • Suicidality: every visit for 3 months, at every dose change either way, then every 3 months. Instruct caregivers to watch for behaviour change at home
  • Activation and mania: screen for bipolar history before the first dose, then ask about reduced sleep need and pressured speech every 3 months
  • Growth and weight: plot at baseline, every 3 months for the first year, then every 6 months. Act on a loss over 7%
  • Hyponatremia and bleeding: check sodium for new headache or confusion; ask about bruising, nosebleeds and purpura every 3 months
  • Urine drug screening: FALSE-POSITIVE benzodiazepine immunoassays for days after stopping; confirm by mass spectrometry
  • Response: do not judge OCD efficacy before full titration and 12 weeks; reassess every 6 months, with sexual function

Discontinuation & Taper

  • Sertraline must be tapered; label 2.6 directs gradual reduction, and the 26-hour half-life gives no cushion.
  • The contrast that drives drug choice: Prozac is effectively self-tapering. Where a family may run out of a refill, pick fluoxetine.
  • Discontinuation reactions include nausea, sweating, dysphoric mood, irritability, dizziness, electric shock sensations, TINNITUS and SEIZURES.
  • If intolerable symptoms follow a reduction, return to the previous dose and go slower.
  • Drug holidays are not appropriate; a break produces a discontinuation syndrome, not a pause.

Pregnancy & Lactation

  • Pregnancy: first-trimester studies and meta-analysis show no increase in total or cardiac malformations against background.
    • Later exposure may raise the risk of persistent pulmonary hypertension of the newborn and neonatal respiratory support.
    • Weigh rather than abstain: women who stopped antidepressants relapsed more often.
    • The ORAL SOLUTION contains 12% alcohol and is not recommended in pregnancy.
  • Lactation: low levels in human milk, with no adverse reactions in a pooled analysis.
    • Relative infant dose about 0.5% to 1%; most authoritative reviewers consider sertraline preferred during breastfeeding (LactMed 2026).
    • Exceptions: neonatal sleep myoclonus, restlessness, diarrhea or agitation, and reduced milk supply (LactMed 2026).
  • Exposure Registry: National Pregnancy Registry for Antidepressants, 1-866-961-2388, womensmentalhealth.org

Counseling Points

  • Counsel the family on:

    • Nothing much happening for two to three weeks; the OCD trial ran 12 weeks.
    • The same time daily, never skipping a weekend; stopping produces withdrawal, not an absent effect.
    • Splitting the scored tablet if the starting dose is too much, rather than skipping days.
    • The liquid: only the supplied dropper, mixed into half a cup of water or juice, drunk straight away.
    • Never accepting a 150 mg or 200 mg capsule while starting or titrating.
    • A urine drug screen reading positive for benzodiazepines for days after stopping.

  • Advise them to call for:

    • New or worsening talk of self-harm, or an abrupt mood change after a dose change.
    • Days without needing sleep, much faster speech, or a jump in energy.
    • New hitting or aggression, or a child dry at night wetting again.
    • Shivering, twitching, stiffness, racing heart, sweating and confusion together.
    • A seizure, especially after missed doses or an abrupt stop.

References

  1. DailyMed. Zoloft (sertraline) tablets and oral solution. Viatris Specialty LLC. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7
  2. DailyMed. Sertraline HCl capsules. Almatica Pharma LLC, NDA 215133. 2023. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c8bcba9-eaeb-aa44-f9ea-b580de55a439
  3. LactMed. Sertraline. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501191/
  4. AHRQ. Anxiety in children. CER No. 192, 17-EHC023-EF. 2017. https://www.ncbi.nlm.nih.gov/books/NBK476277/
  5. Potter. Sertraline in young children with autism spectrum disorder. Frontiers in Psychiatry. 2019. https://pmc.ncbi.nlm.nih.gov/articles/PMC6851992/
  6. FDA. NDC Directory, openFDA, generic name sertraline. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22sertraline%22&limit=1000
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