Pharmaceutical Name

Trade (marketing or proprietary) name: Zoloft

Generic (nonproprietary or active ingredient) name: sertraline hydrochloride tablets

Indication and Usage

Reason the product has been approved for sale on the market.

The FDA has approved this drug as a selective serotonin reuptake inhibitor (SSRI) for the treatment of:

• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Post-traumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD)

Manufacturer Insert

Ingredients

Sertraline hydrochloride, dibasic calcium phosphate dihydrate, D&C Yellow #10 aluminum lake (in 25 mg tablet), FD&C Blue #1 aluminum lake (in 25 mg tablet), FD&C Red #40 aluminum lake (in 25 mg tablet), FD&C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

ZOLOFT is contraindicated in patients:

• Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome.
• Taking pimozide.
• With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema).

In addition to the contraindications for all ZOLOFT formulations listed above, ZOLOFT oral solution is contraindicated in patients:

• Taking disulfiram. ZOLOFT oral solution contains alcohol, and concomitant use of ZOLOFT and disulfiram may result in a disulfiram-alcohol reaction.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebotreated patients. The drug placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.

It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.

Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing ZOLOFT, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

Serotonin Syndrome: Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including ZOLOFT, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome can also occur when these drugs are used alone.

Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

The concomitant use of ZOLOFT with MAOIs is contraindicated. In addition, do not initiate ZOLOFT in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking ZOLOFT, discontinue ZOLOFT before initiating treatment with the MAOI [See Contraindications (4), Drug Interactions (7.1)].

Monitor all patients taking ZOLOFT for the emergence of serotonin syndrome. Discontinue treatment with ZOLOFT and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of ZOLOFT with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.

Increased Risk of Bleeding: Drugs that interfere with serotonin reuptake inhibition, including ZOLOFT, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.

Inform patients of the increased risk of bleeding associated with the concomitant use of ZOLOFT and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio.

Activation of Mania or Hypomania: In patients with bipolar disorder, treating a depressive episode with ZOLOFT or another antidepressant may precipitate a mixed/manic episode. In controlled clinical trials, patients with bipolar disorder were generally excluded; however, symptoms of mania or hypomania were reported in 0.4% of patients treated with ZOLOFT. Prior to initiating treatment with ZOLOFT, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Discontinuation Syndrome: Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

Seizures: ZOLOFT has not been systematically evaluated in patients with seizure disorders. Patients with a history of seizures were excluded from clinical studies. ZOLOFT should be prescribed with caution in patients with a seizure disorder.

Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs including ZOLOFT may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles.

Hyponatremia: Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including ZOLOFT. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients with symptomatic hyponatremia, discontinue ZOLOFT and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs.

False-Positive Effects on Screening Tests for Benzodiazepines: False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking
ZOLOFT. This finding is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of ZOLOFT. Confirmatory tests, such as gas chromatography/mass spectrometry, will help distinguish ZOLOFT from benzodiazepines.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Increased coagulation times (altered platelet function), AV (Atrioventricular) block, Bradycardia (slow heart rate), Atrial arrhythmias (irregular heart beat), QT-interval prolongation (heart muscle takes longer than normal to recharge between beats), Ventricular tachycardia (including Torsade de Pointes – abnormal heart rhythm that can lead to sudden cardiac death), Angioedema (swelling), Hyponatremia, Hyperglycemia, Serotonin syndrome, Extrapyramidal symptoms:, Akathisia (inner restlessness accompanied by mental distress and an inability to sit still), Decreased libido, Dystonia (twisting and repetitive movements or abnormal fixed postures), Oculogyric crisis (prolonged involuntary upward deviation of the eyes), Psychosis (difficulty determining what is real and what is not real), Paroniria (excess of morbid dreams and nightmares), Photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), Vasculitis (group of disorders that destroy blood vessels by inflammation), Pancreatitis, Optic neuritis, Tachycardia (increased heart rate), Tinnitus (ringing in the ears), Hypothyroidism, Mydriasis (dilated pupils), Blurred vision, Hematochezia (passage of fresh blood through the anus), Melena (dark black, tarry feces), Rectal hemorrhage, Severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), Aplastic anemia (body fails to produce blood cells in sufficient numbers), Pancytopenia, Leukopenia, Thrombocytopenia, Lupus-like syndrome, Serum sickness, Gynecomastia (abnormal non-cancerous enlargement of one or both breasts in males), Cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and CallFleming syndrome), Angle-Closure Glaucoma (damage to the optic nerve and potential vision loss), Activation of mania/hypomania for bipolar patients, Nausea, Diarrhea/loose stool, Tremor, Dyspepsia (indigestion), Decreased appetite, Hyperhidrosis (abnormally increased sweating), Ejaculation failure, Enuresis (bed-wetting), Hyperprolactinemia (abnormally high levels of prolactin in the blood), Menstrual irregularities, Pulmonary hypertension (increased blood pressure in the arteries of the lungs), Acute renal (kidney) failure, SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion), Blindness, Cataract (cloudy area in the lens of the eye that leads to a decrease in vision), Agranulocytosis (severe and dangerous lowered white blood cell count), Edema, Gait disturbance, Irritability, Pyrexia (fever), Elevated liver enzymes, Anaphylaxis, Diabetes mellitus, Hypercholesterolemia (high cholesterol), Hypoglycemia (low blood sugar), Increased appetite, Arthralgia (joint pain), Muscle spasms, Tightness, Twitching, Ataxia (lack of voluntary coordination of muscle movements), Coma, Decreased alertness, Hypoesthesia (numbness), Hematuria (presence of blood or red blood cells in the urine), Galactorrhea (spontaneous flow of milk from the breast), Vaginal hemorrhage, Priapism (penis remains erect for hours in the absence of stimulation or after stimulation has ended), Alopecia (balness), Dermatitis bullous (inflammatory lesion of the skin with the formation of fluid), Pruritus (itchiness), Purpura (red/purple spots), Convulsion, Lethargy (state of tiredness, sleepiness, weariness, fatigue, sluggishness or lack of energy), Psychomotor hyperactivity (mood disorders), Syncope (fainting), Aggression, Bruxism (excessive teeth grinding or jaw clenching), Confusional state, Euphoric mood, Hallucination, Bronchospasm (sudden constriction of the muscles in the walls of the bronchioles), Epistaxis (nosebleed), Yawning, Cold sweat, Dermatitis, Hemorrhage (bleeding from a damaged blood vessel), Hypertension (high blood pressure), Vasodilation (widening of blood vessels), Erythematous (skin redness), Follicular/maculopapular rash, Urticaria (hives). Indication-specific adverse reactions: MDD: somnolence; OCD: insomnia, agitation; PD: constipation, agitation; PTSD: fatigue; PMDD: somnolence, dry mouth, dizziness, fatigue, and abdominal pain; SAD: insomnia, dizziness, fatigue, dry mouth, malaise.

Specific Populations

Pregnancy

There are clinical considerations regarding neonates exposed to SSRIs and SNRIs, including ZOLOFT, during the third trimester of pregnancy. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD. ZOLOFT oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy.

Exposure to SSRIs and SNRIs, including ZOLOFT in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). When treating a pregnant woman with ZOLOFT during the third trimester, carefully consider both the potential risks and benefits of treatment. Monitor neonates who were exposed to ZOLOFT in the third trimester of pregnancy for PPHN and drug discontinuation syndrome.

Neonates exposed to ZOLOFT and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on postmarketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome.

For more information about SSRIs during pregnancy, see the “Depression” section of the Motherhood Guide.

Breastfeeding

Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk. There are no data on the effects of sertraline on milk production.

Fertility

A decrease in fertility was seen in one of two rat studies at a dose of 80 mg/kg (3.1 times the maximum recommended human dose on a mg/m2 basis in adolescents).

Pediatric

Safety and effectiveness in pediatric patients in patients with OCD below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD. Two placebo-controlled trials were conducted in pediatric patients with MDD, but the data were not sufficient to support an indication for use in pediatric patients.

Monitoring Pediatric Patients Treated with ZOLOFT: Monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases. Decreased appetite and weight loss have been observed with the use of SSRIs. Monitor weight and growth in pediatric patients treated with an SSRI such as ZOLOFT.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

Analytical Deep Dive

What is informed consent?

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