What It Is: A second-generation antipsychotic
What It's Approved to Treat: Schizophrenia, bipolar disorder and major depressive disorder (adjunct)
Common Off-label Uses: Dementia, depression, generalized anxiety disorder, OCD
Antipsychotics are increasingly being used for off-label purposes, and quetiapine (Seroquel) is the most common among them. The drug was originally registered in 1997 and was the fifth highest-selling pharmaceutical in the U.S. by 2010. But that same year, the government alleged non-psychiatrists were using the drug for off-label uses like anger management, sleeplessness and depression [source: Brett]. A 2007 study found that clinicians reported using the drug off label because it has low abuse potential, has a mildly sedative effect with low risk of confusion, and modest cardiovascular effects.
However, like other drugs in its class, it's been associated with weight gain and dyslipidemia (excess of triglycerides in the blood) and carries a black-box warning for stroke risk in elderly people. Plus, experts aren't quite clear on whether there's strong evidence to support the use of quetiapine for these off-label uses. In fact, in 2010, the drug's manufacturer agreed to pay a $520 million fine for allegations of promoting off-label prescriptions, mostly in low doses of 25 mg. for such as anger management, dementia and sleeplessness. The usual therapeutic dose range for the approved indications of schizophrenia or bipolar disorder is 400 to 800 mg. per day [Brett].
One of the study's authors said that in his clinical experience, "there's no report in the literature showing either that it's efficacious or really that it's safe in those low [25 mg.] doses" [source: Busko].