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News From the Food and Drug Administration
February 2, 2000

Sertraline Approved for Posttraumatic Stress Disorder

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JAMA. 2000;283(5):596. doi:10.1001/jama.283.5.596-JFD00000-3-1

The FDA has approved sertraline hydrochloride (Zoloft, Pfizer Inc, New York, NY) as the first drug treatment for posttraumatic stress disorder (PTSD). The drug had been approved to treat depression, obsessive compulsive disorder, and panic disorder.

According to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, a diagnosis of PTSD requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response of intense fear, helplessness, or horror. Symptoms of PTSD, which must be present for more than 1 month, include reexperiencing and intrusion of the traumatic event; avoidance of situations reminiscent of it; numbing of general responsiveness; irritability; sleep disturbance; impaired concentration; and outbursts of anger. The disturbance must cause clinically significant distress or impairment of functioning.