Zoloft / Sertraline Medication Profile

Zoloft® (sertraline HCl) is a type of antidepressant known as a selective serotonin reuptake inhibitor or SSRI. It works by making more of the brain hormone serotonin available between nerve cells.

Conditions Treatable with Zoloft

The US Food and Drug Administration (FDA) has approved Zoloft for the treatment of adults over age 18 diagnosed with:

• depression
• social anxiety disorder
• posttraumatic stress disorder (PTSD)
• panic disorder
• obsessive-compulsive disorder (OCD), and
• premenstrual dysphoric disorder (PMDD)

Zoloft is also approved for OCD in children and adolescents aged 6-17 years.

Important Cautions

• You should not take Zoloft if you're taking a monoamine oxidase inhibitor (MAOI) or pimozide, and there should be a two-week break between stopping or starting Zoloft and starting or stopping on MAOI. Serious, even fatal, complications can occur when these types of drugs are combined.
• The manufacturer advises that you should not drink alcohol while taking Zoloft.
• Do not discontinue Zoloft without talking to your doctor. You should also not stop taking Zoloft all at once to avoid SSRI discontinuation syndrome.
• It could take up to eight weeks before your symptoms start to improve.
• Be aware that any antidepressant has the possibility of triggering hypomania or mania, although in clinical trials, this was rare (0.4%) with Zoloft.

Dosage and Administration

• The initial dosage of Zoloft is generally 25-50 mg, depending on the age of the patient and the illness being treated.
• The maximum recommended dose is 200 mg.
• Take Zoloft once daily, morning or evening.
• Zoloft can be taken with or without food.

Pregnancy

In March 2006 Health Canada issued a warning for SSRI antidepressants saying that there could be complications for infants born to mothers taking any of these medications, including Zoloft, during the third trimester of pregnancy. The manufacturer's prescribing information states, "Zoloft should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."

Side Effects

The most common side effects of Zoloft include:

• Decreased appetite or weight loss
• diarrhea or loose stools
• dizziness
• drowsiness
• dry mouth
• headache
• increased sweating
• nausea
• stomach or abdominal cramps, gas, or pain
• tiredness or weakness
• trembling or shaking
• trouble sleeping

All SSRI antidepressants have the potential to cause weight gain (which may be substantial) with long-term use.

Black Box Warning

The FDA has mandated that all SSRI antidepressants carry the following warning contained in a bold black box:

Suicidality in Children and Adolescents Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Zoloft is not approved for use in pediatric patients except for patients with Obsessive Compulsive Disorder (OCD). (See Warnings and Precautions: Pediatric Use)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

According to RxList.com, approximately 5.5% of persons who overdosed on Zoloft are known to have died or suffered serious aftereffects.

Disclaimer: This profile is not intended to be all-inclusive or to replace information provided by your doctor or with the prescription from the manufacturer.

References:

• Zoloft. 20 July 2006.
• Zoloft / sertraline hydrochloride. RxList. 10 September 2005. 20 July 2006.
• Advisory - Newer antidepressants linked to serious lung disorder in newborns. Health Canada. 10 March 2006. 20 July 2006.