Quetiapine, a short-acting atypical anti-psychotic drug for the treatment of bipolar I disorder and schizophrenia, is increasingly used off-label for the treatment of sleep disturbances or insomnia. However, data supporting this off-label prescription of quetiapine are limited.

To report and discuss the effects of “off-label” use of quetiapine for the treatment of sleep disturbances.

An English-language literature search was conducted using Pubmed, EMBASE and Cochrane library (December 1980–December 2015) using the search terms quetiapine, insomnia, sleep disorders, sleep disturbances, and sleeplessness.

During the last decade, there is an enormous increase in prescribing quetiapine. This anti-psychotic drug is among the best selling drugs worldwide. For the approved indications, the usual therapeutic dose range is 400–800mg/day. However, off-label use of quetiapine was most evident for the 25mg/day to 100mg/day. In some countries, off-label uses are promoted to non-psychiatrists for the treatment of insomnia, dementia, agitation, and aggression. Inappropriate anti-psychotic use may lead to serious health problems, including metabolic effects, increased sudden cardiac death, and age-related side effects with increased risk for orthostatic hypotension, fractures, pneumonia, cognitive impairment, and stroke.

There is growing concern regarding the potential harm from off-label prescription of anti-psychotics, particularly quetiapine. There is little evidence supporting the enormous off-label uses of quetiapine. In addition, prescribing quetiapine for indications that are not evidence based has ethical, financial, and safety implications, especially in the older population.