Sertraline
,
post-traumatic stress disorder (
PTSD)
,
premenstrual dysphoric disorder (
PMDD)
,
panic disorder (
PD)
and
social phobia/social anxiety disorder.
Unapproved, off-label, and investigational
Sertraline can also be used in the treatment of
generalized anxiety disorder,
binge eating disorder ,
premature ejaculation.
There is also evidence that sertraline may be effective in the treatment of refractory
neurocardiogenic syncope in children and
adolescents.
A study has shown that sertraline is an effective treatment for impulsive aggressive behavior in
personality disordered patients.
Sertraline can have a number of adverse effects, including
insomnia,
asthenia, gastrointestinal complaints, tremors, confusion, dizziness,
anorgasmia, and decreased
libido; it can induce
mania or
hypomania in around 0.5% of patients. It has also been known to cause minor weight loss. It is
contraindicated in individuals taking
MAOIs or undergoing
electroconvulsive therapy.
Until 2003 Zoloft 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. In
June 2004, Britain banned Zoloft's use by minors and in
February 2005, Pfizer was forced to change Zoloft's labeling to include information regarding increased incidences of suicidal behavior and depression in adolescent users of the drug. According to mentalhealth.com, Zoloft is not currently recommended or advised for use in individuals under the age of 18. After these changes, multiple incidences and at least one medical study showed an increased suicide risk in seniors who were taking Zoloft. In response to these findings, the FDA released a public health warning. This warning indicates that anyone currently using Zoloft for any reason has a greater chance of exhibiting suicidal thoughts or behaviors regardless of age. This warning is questionable, however, due to the types of illnesses Zoloft is used to treat, it is impossible to determine if these tendencies are a side effect of the drug or the illness the drug is meant to treat. Zoloft should still truly be only recommended in rather persistant cases as drugs such as these are still in the arena of the unknown.
Zoloft has long been seen as the best option for breastfeeding mothers who wish to continue breastfeeding and be able to take their antidepressants. Despite its apparent safety and effectiveness during the breastfeeding period, recent studies and consumer complaints have seen a need to alter Zoloft's labeling regarding use during the third trimester of pregnancy. Though there are no teratogenetic defects associated with Zoloft, there is reason to be concerned about its effects on infants who were exposed to sertraline during the third trimester in utero. It seems that Zoloft use in late pregnancy significantly increases the potential need for hospitalization and breathing assistance in the newborn period and has also been shown to cause an increased risk of neonatal death. In light of this increased risk it is still being used due to the greater potential risk of a seriously depressed mother to herself and her unborn child. Like all other medications Zoloft's use must be decided only after carefully weighing out all potential risks and benefits.
Sertraline is manufactured by
Pfizer and sold as Zoloft in the United States as small green 25
mg tablets, blue 50 mg tablets, and yellow 100 mg tablets (Generic 100 mg sertraline tablets are also yellow), each of which is scored to allow easy halving. In the UK, the brand name is
Lustral and is available in white 50 mg or 100 mg tablets, according to the
British National Formulary (BNF).
In Australia, only the 50 mg and 100 mg strengths are available, both as white tablets. Sertraline is an odorless, white, sparingly soluble crystalline solid. The minimum effective dose is 50 mg per day, but lower doses may be used in the initial weeks of treatment to acclimate the patient's body, especially the liver, to the drug and to minimize the severity of any side effects. Patients who do not experience relief of symptoms at 50 mg a day may have their dose increased, up to 200 mg a day.
The patent for this brand-name drug expired in December 2005. It is expected it will be available in
generic form in the United States by the end of September 2006 (source: www.bloomberg.com). Manufacturers include Andrx, Aurobindo, Genpharm, Teva,
Mylan and Roxane. In Scandinavia a generic drug called Sertralin, manufactured by
HEXAL is available. The price differences between Zoloft® and Sertralin® are as much as 1.50
dollars per pill.
Because of its
metabolism,
liver impairment can affect the
elimination of this drug from the body. If someone with liver impairment is treated with sertraline, lower or less frequent dosage should be used. Similarly, patients should limit their
alcohol intake while on sertraline (or any antidepressant). Because the liver is doubly taxed with processing both substances (in addition to any other drugs the patient may be taking), alcohol remains in the bloodstream longer, so the effects of alcohol may be more strongly and quickly felt by people taking sertraline or other antidepressants. According to some studies grapefruit juice might interfere with the metabolisation of sertraline, increasing its concentration in the blood.
Sertraline appears to also be a minor
dopamine reuptake inhibitor. At higher dosages (300 mg/day), sertraline inhibits the reuptake of
dopamine as well as serotonin.
In
June 2003,
Britain banned sertraline's use for patients under 18 years of age after studies showed a link to increasing suicidal rates. Similar concern has prevailed in the United States, where only the anti-depressant
fluoxetine (another
SSRI) was officially banned by the FDA for the treatment of depression in minors. However, because the antidepressant-suicide link is correlational, scientists do not know whether the increased suicide risk for people taking antidepressants occurs because the drugs make people suicidal, whether suicide occurs because the drugs un-depress the people enough to motivate the energy required to commit suicide (a popular theory), or because of a third, unknown factor.
Zoloft, along with other
SSRIs, has been associated with a "cessation syndrome." This syndrome has both
somatic and psychological elements, although SSRIs fall short of being classified as
addictive. This non-addictive classification stems from the fact persons given the drug will not seek it out in ever-increasing quantities. Although Zoloft is defined as non-habit forming, the existence of
SSRI discontinuation syndrome often necessitates a gradual tapering of one's prescribed dose when seeking to stop SSRI therapy. The prescription insert for Zoloft describes the potential side effects SSRI discontinuation as follows:
During marketing of Zoloft and other SSRIs and SNRIs (Serotonin and Norepinephrine ReuptakeInhibitors), there have been spontaneous reports of adverse events occurring upondiscontinuation of these drugs, particularly when abrupt, including the following: dysphoricmood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as electricshock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, andhypomania. While these events are generally self-limiting, there have been reports of seriousdiscontinuation symptoms. [1]
A major study funded by the
NIH in the United States, found a sertraline product to be ineffective in treating major depression of moderate severity. (Hypericum Depression Trial Study Group, 2002) This study involved 340 patients, diagnosed with Major Depressive Disorder based on
DSM-IV criteria and assessed using
Hamilton Depression Rating Scale (HAM-D) and
Clinical Global Impression (CGI) scores. The trial was a multi-centre randomised double-blind placebo-controlled trial, comparing one preparation of
St John's wort (Li 160) to sertraline and placebo. Li 160 proved no more effective than placebo in alleviating moderately severe major depression. Sertraline was also no better than placebo in this study, based on the primary outcome measure (HAM-D).
*Pfizer's official
Zoloft website
*Medlibrary.org's "
Latest medical literature on zoloft" — medical literature research abstracts, (page last modified
26 May 2006 as of
5 August 2006)
*
WebMD - Drugs - Sertraline — dosage and other drug interaction information
*
WebMD - Drugs - Zoloft tablet pictures*Hosted at Biopsychiatry.com, Pfizer's
Zoloft patient information leaflet (PDF Document, 260900 bytes, 43 pages, modified: 20 July 05)
