Clonidine (Catapres) has been FDA-approved for use in hypertension since the early 1970s. Because of its well-recognized ability to downregulate noradrenergic output from the CNS, it is possible to use it in psychiatric disorders characterized by excessive autonomic nervous system arousal, such as hyperactivity and impulsivity. The FDA does not presently label clonidine for any indication in child and adolescent psychiatry; however, some clinicians continue to use clonidine in a variety of early-onset psychiatric conditions. It is considered a third-line medication for overarousal, impulsivity, excessive hyperactivity, and explosive outbursts of aggression in children and adolescents with ADHD who have not responded to stimulants, atomoxetine, or antidepressants. It may also be used in combination therapy with stimulants to decrease overarousal and to treat sleep disturbances.

In June 2008, Sciele Pharma, a pharmaceutical company specializing in therapeutic agents for the well being of children, announced they have completed patient enrollment for its first Phase III clinical trial in the United States for Clonicel as treatment of ADHD disorder. Clonicel is a sustainedrelease formulation of clonidine hydrochloride for the treatment if ADHD and hypertension. The drug is a combination of stimulants such as methylphenidate and dextro-amphetamine/amphetamine. In earlier phase test Clonicel has shown to alleviate debilitating symptoms associated with ADHD, especially hyperactivity, impulsivity, and aggression. The goal of this formulation is to provide an option for patients who need an alternative to stimulants or who may benefit from combination therapy using Clonicel with other approved ADHD medications.

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