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Fact Table
| Fact Table | |
|---|---|
| Formula | C17H17Cl2N·HCl (sertraline hydrochloride); C17H17Cl2N (sertraline base) |
| License | FDA approved (NDA 019839; initial U.S. approval 1991) |
| Bioavailability | ~44% oral; food causes a small increase in Cmax and AUC |
| Legal status | Prescription only (Rx-only) |
| Chemical Name | (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride |
| Elimination half-life | Sertraline ~26 hours; N-desmethylsertraline ~62–104 hours |
| Dosage (Strength) | Tablets 25 mg, 50 mg, and 100 mg; oral solution 20 mg/mL; usual adult dosing 25–50 mg once daily initially, titrated up to 200 mg/day depending on indication and response |
| Pregnancy | Use only if benefits justify risks; epidemiologic data are inconclusive for specific defects; neonates exposed late in pregnancy may have SSRI/SNRI-related complications; oral solution contains alcohol and is not recommended during pregnancy |
| Brands | Zoloft; Lustral; generics available |
| Protein binding | ~98% bound to serum proteins |
| PubChem CID | 68617 (sertraline); 63009 (sertraline hydrochloride) |
| MedlinePlus | a697048 |
| ChEBI | 9123 (sertraline); 9124 (sertraline hydrochloride) |
| ATC code | N06AB06 |
| DrugBank | DB01104; DBSALT000808 (sertraline hydrochloride) |
| KEGG | D02360 (sertraline); D00825 (sertraline hydrochloride) |
| Routes of administration | By mouth (oral tablets; oral solution/concentrate) |
Zoloft (sertraline) is an antidepressant used to treat several mental health conditions in adults, including major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD). It belongs to a class of medications called selective serotonin reuptake inhibitors (SSRIs), which work by increasing serotonin levels in the brain to help regulate mood. It is available as film-coated tablets in 25 mg, 50 mg, and 100 mg strengths, as well as an oral liquid solution.
Directions
Take Zoloft once daily, either in the morning or evening, with or without food. For most conditions, treatment starts at 25 to 50 mg per day and may be gradually increased in 25 to 50 mg increments once a week, up to a maximum of 200 mg per day. The oral concentrate must be diluted in 4 ounces (half a cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice immediately before taking it. Do not take more than prescribed, and do not stop taking Zoloft without first consulting a healthcare provider.
Ingredients
The active ingredient in Zoloft tablets is sertraline hydrochloride. Inactive ingredients may include calcium phosphate dibasic, hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, FD and C Blue No. 1 aluminum lake (25 mg tablets), FD and C Red No. 40 aluminum lake (50 mg tablets), FD and C Yellow No. 6 aluminum lake (100 mg tablets), titanium dioxide, and magnesium stearate. The oral concentrate may contain glycerin, alcohol (12%), menthol, and butylated hydroxytoluene.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Antidepressants, including Zoloft, may increase the risk of suicidal thinking in children, teens, and young adults. All patients starting Zoloft should be monitored closely for unusual changes in mood or behavior.
Combining Zoloft with other serotonergic drugs, such as triptans, other antidepressants, tramadol, or St. John’s wort, may cause a serious reaction with agitation, rapid heart rate, high temperature, and muscle twitching.
SSRIs like Zoloft may increase the risk of bleeding, especially when combined with blood thinners, aspirin, or anti-inflammatory medications.
Starting an antidepressant alone in a patient with undiagnosed bipolar disorder can trigger a manic episode; screen for bipolar disorder before starting treatment.
Zoloft may trigger acute narrow-angle glaucoma in people who are at risk.
SSRIs can cause a drop in blood sodium, particularly in older adults. Watch for signs such as headache, weakness, or confusion.
Use this drug with caution if you have a history of seizure disorders.
Contraindications
Avoid taking or using this medication if any of the following apply:
- Currently taking or recently stopped taking monoamine oxidase inhibitors (MAOIs); at least 14 days must pass between stopping an MAOI and starting Zoloft, and vice versa
- Currently taking pimozide
- Known allergy or hypersensitivity to sertraline or any ingredient in Zoloft
- Currently using disulfiram, if taking the liquid formulation of Zoloft
Side Effects
Common side effects of Zoloft include:
- Nausea
- Diarrhea or loose stools
- Dry mouth
- Insomnia
- Dizziness
- Fatigue
- Sweating
- Anxiety
- Decreased appetite
- Sexual side effects, such as delayed ejaculation, decreased libido, or difficulty reaching orgasm
- Tremor
Serious side effects include serotonin syndrome, severe allergic reactions such as Stevens-Johnson syndrome, dangerous drops in blood sodium levels, increased bleeding events, liver injury, and abnormal heart rhythms, including QT prolongation.
There is also a risk of suicidal thoughts, particularly in people under 25 years of age.
Newborns exposed to Zoloft late in pregnancy may experience withdrawal symptoms or, rarely, a lung condition called persistent pulmonary hypertension.
Contact a healthcare provider promptly if any serious symptoms develop.
Frequently Asked Questions about Zoloft
What is Zoloft?
Zoloft is a brand-name medication that contains sertraline hydrochloride. It belongs to a class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs, which affect serotonin activity in the brain.
What is Zoloft used for?
Zoloft is used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder. In children and adolescents, its approved use is for obsessive-compulsive disorder.
How does Zoloft work?
Zoloft works by inhibiting the reuptake of serotonin, which helps increase serotonin availability in the nervous system. This may improve symptoms related to depression, anxiety, intrusive thoughts, panic attacks, and mood changes associated with certain conditions.
How is Zoloft usually taken?
Zoloft is taken by mouth, usually once daily, either in the morning or evening. It is available as tablets and as an oral solution, and it may be taken with or without food. The dose and schedule should follow the prescriber’s instructions.
How long does Zoloft take to work?
Some symptoms, such as sleep, appetite, or energy, may begin improving earlier, but mood and anxiety symptoms often take several weeks to show meaningful improvement. Full benefit may take longer, and dosing adjustments are sometimes needed under medical supervision.
What are common side effects of Zoloft?
Common side effects may include nausea, diarrhea, indigestion, decreased appetite, increased sweating, tremor, tiredness, insomnia or sleepiness, agitation, anxiety, and sexual side effects such as decreased libido or delayed ejaculation.
What serious side effects should be watched for?
Serious risks can include worsening depression, suicidal thoughts or behavior especially in younger patients, serotonin syndrome, abnormal bleeding, seizures, manic episodes, low sodium levels, eye pressure problems, and severe allergic reactions. Any severe, unusual, or rapidly worsening symptoms need prompt medical attention.
Who should not take Zoloft?
Zoloft should not be used with monoamine oxidase inhibitors, pimozide, or in people with a known allergy to sertraline. The oral solution also contains alcohol and should not be used with disulfiram. Certain drug combinations can increase the risk of serious reactions.
Can Zoloft be stopped suddenly?
Zoloft should generally not be stopped abruptly unless a healthcare professional instructs otherwise. Sudden discontinuation may cause symptoms such as dizziness, irritability, nausea, headache, sleep disturbance, anxiety, tingling sensations, or mood changes.
How should Zoloft be stored?
Zoloft should be stored at room temperature, typically 68°F to 77°F, with the container kept tightly closed. It should be kept out of reach of children and stored away from unsafe heat, moisture, or direct misuse.
