The concomitant use of Zoloft with MAOIs intended to treat depression is contraindicated (see CONTRAINDICATIONS and WARNINGS – Potential for Interaction with Monoamine Oxidase Inhibitors).

Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome may occur in treatment with SNRIs and SSRIs, including Zoloft, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

If concomitant treatment of SNRIs and SSRIs, including Zoloft, with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see PRECAUTIONS – Drug Interactions).

The concomitant use of SNRIs and SSRIs, including Zoloft, with serotonin precursors (such as tryptophan) is not recommended (see PRECAUTIONS – Drug Interactions).

Neuroleptic Malignant Syndrome (NMS) or NMS-Like Reactions
Rare instances of neuroleptic malignant syndrome (NMS) or NMS-like reactions have been reported when a selective serotonin reuptake inhibitor (SSRI) drug, such as sertraline, or a serotonin-norepinephrine reuptake inhibitor (SNRI) was added to antipsychotic drug therapy. Additionally, a small number of such cases have been reported with SSRI's and SNRI's in the absence of antipsychotic coadministration. These serious and sometimes fatal events can include hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. It is uncertain whether these cases are serotonin syndrome which, in its most severe form, can resemble neuroleptic malignant syndrome. As these events may result in potentially life-threatening conditions, patients should be monitored for the emergence of NMS-like signs and symptoms, especially if sertraline and an antipsychotic drug are taken concurrently. Treatment with sertraline and any concomitant antipsychotic agent should be discontinued immediately if such events occur and supportive symptomatic treatment should be initiated.

PRECAUTIONS

General

Activation of Mania/Hypomania
During premarketing testing, hypomania or mania occurred in approximately 0.4% of ZOLOFT (sertraline hydrochloride) treated patients.

Weight Loss
Significant weight loss may be an undesirable result of treatment with sertraline for some patients, but on average, patients in controlled trials had minimal, 1 to 2 pound weight loss, versus smaller changes on placebo. Only rarely have sertraline patients been discontinued for weight loss.

Seizure
ZOLOFT has not been eva luated in patients with a seizure disorder. These patients were excluded from clinical studies