Dr. Shahal Rozenblatt, Clinical Neuropsychologist, New York

FDA approvals: A new ADHD treatment for six-year-olds

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The Food and Drug Administration (FDA) has approved a new type of drug, an alpha-2A adrenergic receptor agonist, to treat attention-deficit hyperactivity disorder (ADHD) in children as young as six.

The new ADHD drug, gunafacine (Intuniv), is from Shire Pharmaceuticals. The approval is for children ages 6 to 17 years of age. It will come in four dosage strengths, 1, 2, 3, and 4 mg, and is a nonscheduled medication. Its common adverse events include somnolence, headache, fatigue, upper abdominal pain, and sedation.

Guanfacine (brand name Tenex, and the extended release Intuniv) is an agonist of the α2A subtype of norepinephrine receptors. These receptors are concentrated heavily in the prefrontal cortex and the locus ceruleus, with the potential to improve attention abilities via modulating post-synaptic α-2a receptors in the prefrontal cortex.[1] Guanfacine lowers both systolic and diastolic blood pressure by activating the central nervous system α-2a norepinephrine autoreceptors, which results in reduced peripheral sympathetic outflow and thus a reduction in peripheral sympathetic tone.[2] Its side-effects are dose dependent, with frequency and severity almost disappearing at doses of 2 mg and less.[3] See the Side Effects section for further information. Withdrawal syndrome contains confounds making it a subject for debate, and tolerance is not observed.[3]