Even though the US Food and Drug Administration (FDA) has not approved any medication for the treatment of insomnia in pediatric patients, more than 80% of young patients who present with sleep problems will leave with a prescription, finds a new study in the journal Sleep.

Researchers analyzed 12 years of data and more than 18,500,000 patient visits where the primary complaint was insomnia or sleep difficulties and discovered that the rate of prescribing sleep aids off-label for this population was much higher than previous studies had indicated. The study looked at data on infants, children, and teens 17 years of age or younger that had been recorded by the National Ambulatory Medical Care Survey. Among the 81% of these patients who were prescribed medications, 33% received antihistamines such as Atarax (hydroxyzine) and another 26% received alpha-2 agonists such as Catapres (clonidine) and Tenex (guanfacine). Use of nonbenzodiazepines, such as Ambien (zolpidem) or Sonata (zaleplon), was relatively rare. Only 1% received a prescription for these types of drugs.

Sleep medications are prescribed off-label for pediatric patients out of necessity because there is no FDA-approved drug available for them. This may make the use of sleep medications riskier for children because there are few, if any, studies on drug side effects in pediatric patients and little data on how these drugs may impact a brain that is still growing and developing. Likewise, little research has been done on the long-term use of sleep aids in children.