Tuesday, March 31, 2026
The FDA has approved a new, longer-acting generic version of a common ADHD and narcolepsy medication.
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The FDA has approved a new, longer-acting generic version of a common ADHD and narcolepsy medication.

Plain Language Summary
What this means for you:
A new long-acting generic ADHD/narcolepsy drug is now an option. Talk to your doctor to see if it's right for you.

The U.S. Food and Drug Administration (FDA) has approved a new generic medication called methylphenidate hydrochloride extended-release tablets. This drug is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older, as well as adults. It is also approved to treat narcolepsy, a sleep disorder. The 'extended-release' part means the medication is designed to work in the body for about 8 hours after taking a single dose.

This approval is for a generic version, which means it is therapeutically equivalent to a brand-name drug that was already on the market. For patients, this can sometimes mean more availability and potentially lower costs. The approval provides another option for a longer-acting treatment, which some people may prefer over taking multiple doses of a shorter-acting medicine throughout the day.

It is important to know that this medication, like other stimulants, carries a serious warning about the risk of abuse, misuse, and dependence. The label also states it is not recommended for children under 6 years old due to a higher chance of side effects like weight loss. All medications have benefits and risks that must be carefully considered.

The most important step for anyone interested in this new option is to have a conversation with their healthcare provider. Only a doctor who knows a patient's full medical history can determine if this specific medication is a suitable and safe choice for their individual situation.

What this means for you:
A new long-acting generic ADHD/narcolepsy drug is now an option. Talk to your doctor to see if it's right for you.
Read the Full Clinical Summary →
View Original Abstract ↓
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) , Use in Specific Populations (8.4) ] . Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ( 1 ). Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).