# Zoloft ### (sertraline) **[Zoloft](https://wiki.joshnp.com/link/148)** (sertraline); not controlled
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7)
--- ### **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](https://wiki.joshnp.com/link/147) 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](https://wiki.joshnp.com/link/100) from 7 y/o - **Pediatric major depressive disorder** (ICD-10: F32.x): two trials did not support an indication. [Prozac](https://wiki.joshnp.com/link/147) 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](https://wiki.joshnp.com/link/4), 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](https://wiki.joshnp.com/link/36), stack two pediatric suicidality boxed warnings. - **Bupropion** ([Wellbutrin XL](https://wiki.joshnp.com/link/98)): 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](https://wiki.joshnp.com/link/147) 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](https://womensmentalhealth.org/research/pregnancyregistry/antidepressants) --- ### **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