The short-acting formulation of mixed amphetamine salts (Adderall, and generics) FDA-approved for treatment of attention-deficit hyperactivity disorder (ADHD) and narcolepsy, is currently in short supply in the US. Until an adequate supply is restored, patients may be looking for alternatives.

The FDA has approved an extended-release orally disintegrating tablet formulation of methylphenidate (Cotempla XR-ODT – Neos Therapeutics) for once-daily treatment of attention-defi cit/hyperactivity disorder (ADHD) in children 6-17 years old. Cotempla XR-ODT is the first extended-release orally disintegrating tablet formulation of methylphenidate to become available in the US.

Clonidine, an Alpha2-selective adrenergic agonist marketed in the USA only for treatment of hypertension, has also been used in recent years to treat children with attention-deficit/hyperactivity disorder (ADHD).

Xywav (Jazz), an oral solution that contains calcium, magnesium, potassium, and sodium oxybates, has been approved by the FDA for treatment of idiopathic hypersomnia in adults. It is the first drug to be approved in the US for this indication. Xywav was approved in 2020 for treatment of excessive daytime sleepiness or cataplexy in patients ≥7 years old with narcolepsy. It contains about 92% less sodium than sodium oxybate oral solution (Xyrem), which has been available in the US for years for use in patients ≥7 years old with narcolepsy.

The FDA has approved solriamfetol (Sunosi – Jazz), a dopamine and norepinephrine reuptake inhibitor (DNRI), to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). Pitolisant (Wakix), an H3-receptor antagonist/inverse agonist recently approved by the FDA for treatment of excessive daytime sleepiness in patients with narcolepsy, will be reviewed in a future issue.

Modafinil (Provigil), a benzhydryl sulfinylacetamide non-amphetamine stimulant that has been used in Europe since 1995, has now been approved by the FDA for treatment of excessive daytime sleepiness associated with narcolepsy.

The FDA has approved a once-daily, extended-release chewable tablet formulation of methylphenidate (QuilliChew ER – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first long-acting chewable formulation of the drug to be marketed in the US. Immediate-release chewable methylphenidate tablets (Methylin, and generics) have been available since 2003.

Recently pharmaceutical manufacturers have marketed a stereoisomer of a successful drug nearing patent expiration as a new drug. Examples, such as esomeprazole (Nexium) , levalbuterol (Xopenex), escitalopram (Lexapro) and dexmethylphenidate

A transdermal patch formulation of methylphenidate (Daytrana - Noven/Shire) has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥ 6 years old. Like other methylphenidate products, the patch is a schedule II controlled substance. According to the manufacturer, it will be available in pharmacies by the end of June.

The FDA has approved a once-daily, extended-release oral suspension of methylphenidate (Quillivant XR – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first liquid formulation of the drug to be marketed for once-daily use. A short-acting oral solution (Methylin, and generics) has been available since 2003.