What is Zoloft and what does it do?

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Zoloft® (sertraline HCl) is a prescription medicine that treats depression and anxiety. It belongs to a class of drugs known as SSRIs (Selective Serotonin Reuptake Inhibitors). Zoloft works to correct a chemical imbalance in the brain that may be related to symptoms of depression or anxiety. It has been prescribed to millions of people for over 15 years.
What medical conditions is Zoloft approved to treat?
The Food and Drug Administration (FDA) approved Zoloft for the treatment of a number of mood and anxiety disorders including depression, social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder, obsessive-compulsive disorder (OCD) and premenstrual dysphoric disorder (PMDD) in adults over age 18. It is also approved for OCD in children and adolescents age 6-17 years.
How long does it take to feel better with Zoloft?
Every person is unique. The time it takes to feel better is different for everyone. Some of your symptoms might start to improve within one to two weeks or it could take up to eight weeks. Even if you don’t feel better right away, it’s important to keep taking your medicine as directed. Give Zoloft a chance to work for you.
How long will I have to take Zoloft?
Length of treatment is different from person to person. The American Psychiatric Association (APA) recommends all medicines for depression should be taken for six months to one year in order to prevent symptoms from returning. Your doctor will decide how long you need to be on Zoloft. It’s important to keep taking Zoloft as directed. Even if you feel better, you shouldn’t stop taking Zoloft without talking to your doctor first.

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Obsessive-Compulsive Disorder

Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

The efficacy of sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY).

Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

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The efficacy of sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

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HistoryThe history of sertraline goes back to the beginning of 1970s when Pfizer chemist Reinhard Sarges synthesized a norepinephrine reuptake inhibitor tametraline Tametraline’s development was soon stopped because of undesired stimulant effects observed in animals. Several years later, biochemist Kenneth Koe and chemist Willard Welch generated and tested derivatives of tametraline in vitro for the serotonin reuptake inhibition. Welch then prepared stereoisomers of the most promising candidate, which were tested in vivo by animal behavioral scientist Albert Weissman. The most active (+)-cis-isomer was taken into further development and eventually became sertraline. During the development, the group had to overcome the initial reluctance of Pfizer bureaucracy to pursue sertraline, as Pfizer was considering licensing an antidepressant candidate from another company.

Sertraline was approved by the Food and Drug Administration (FDA) in 1991 based on the recommendation of the Psychopharmacological Drugs Advisory Committee. The committee achieved a consensus that sertraline is safe and efficient for the treatment of depression. During the discussion, Paul Leber, Director of the FDA Division of the Neuropharmacological Drug Products noted that it was a “tough decision”, since the treatment effect on outpatients with depression had been “modest to minimal”. Other experts emphasized that the drug’s effect on inpatients had not been different from placebo and criticized poor design of the trials by the drug’s manufacturer Pfizer. For example, 40% of the participants dropped out of the trials, significantly decreasing their validity.

Until 2003, sertraline was only approved for use in adults ages 18 and over; that year it was approved by the FDA for use in treating children ages 6 to 17 with extreme obsessive compulsive disorder (OCD). In 2003 the UK Medicines and Healthcare Products Regulatory Agency issued a guidance that SSRIs, except fluoxetine (Prozac) are not suitable for the treatment of depression in minors,. However, sertraline still can be used for the treatment of OCD in children and adolescents. In 2005 the FDA, changed the labeling of antidepressants, including sertraline, adding a black box warning pertaining to pediatric suicidality, followed in 2007 by the warning regarding the suicidality in young adults.

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The patent for Zoloft brand of sertraline expired in 2006, and the drug is now available in generic form.