The FDA has approved Vyvanse (lisdexamfetamine) to treat moderate to severe binge eating disorder (BED) in adults. Vyvanse is a central nervous system stimulant that was already approved for attention deficit hyperactivity disorder (ADHD) in adults and children aged 6 and older. This new approval provides a medication option for people with BED, a condition where a person has repeated episodes of eating large amounts of food and feels a loss of control during the binge. It is important to know that Vyvanse is not approved for weight loss, and its safety and effectiveness for weight loss or obesity have not been studied. The recommended starting dose for BED is 30 mg once daily, with the dose increased weekly to a target of 50 to 70 mg daily. If binge eating does not improve, treatment should be stopped. If you or someone you know has binge eating disorder, talk to a doctor about whether Vyvanse might be a helpful option. This approval gives patients a new choice, but it is not a quick fix. Always discuss the risks and benefits with your healthcare provider.
FDA approved Vyvanse (lisdexamfetamine) for Binge Eating DisorderFDA approved Vyvanse to treat binge eating disorder in adults
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The FDA has approved Vyvanse (lisdexamfetamine) for the treatment of moderate to severe binge eating disorder (BED) in adults, expanding its previous indication for attention deficit hyperactivity disorder (ADHD). Vyvanse is a central nervous system stimulant that is also indicated for ADHD in adults and children aged 6 years and older. The approval for BED provides a pharmacologic option for patients with this condition, which is characterized by recurrent episodes of binge eating without compensatory behaviors. Clinicians should note that Vyvanse is not indicated for weight loss, and its safety and effectiveness for obesity have not been established. The recommended starting dose for BED is 30 mg once daily, titrated weekly by 20 mg to a target dose of 50-70 mg daily, with a maximum of 70 mg daily. Treatment should be discontinued if binge eating does not improve.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Lisdexamfetamine is a prodrug of dextroamphetamine, a central nervous system (CNS) stimulant. The exact mechanism of action in ADHD and BED is not fully understood, but it is thought to involve the increase of norepinephrine and dopamine in the synaptic cleft.
Vyvanse is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older, and for moderate to severe binge eating disorder (BED) in adults. It is not recommended in pediatric patients younger than 6 years due to higher plasma exposure and increased adverse reactions. Vyvanse is not indicated for weight loss.
For ADHD: Starting dose 30 mg once daily in the morning; may be adjusted by 10 mg or 20 mg weekly up to 70 mg/day. For BED: Starting dose 30 mg once daily; titrate by 20 mg weekly to target 50-70 mg/day; maximum 70 mg/day. Discontinue if no improvement. In severe renal impairment (GFR 15-<30 mL/min/1.73 m2), maximum 50 mg/day; in ESRD (GFR <15 mL/min/1.73 m2), maximum 30 mg/day. Administer orally in the morning with or without food. Capsules may be swallowed whole or opened and mixed with yogurt, water, or orange juice. Chewable tablets must be chewed thoroughly.
For ADHD in pediatric patients ages 6-12: A double-blind, randomized, placebo-controlled study (Study 1) enrolled 290 patients meeting DSM-IV criteria for ADHD. Patients received VYVANSE 30 mg, 50 mg, or 70 mg or placebo once daily for 4 weeks. All patients started on 30 mg for the first week. Trial data for BED: Not reported in label.
Prior to treatment, assess for cardiac disease (history, family history of sudden death or ventricular arrhythmia, physical exam). Evaluate for motor or verbal tics or Tourette's syndrome. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. Avoid afternoon doses due to potential insomnia. Acidifying agents (e.g., ascorbic acid) decrease amphetamine blood levels; alkalinizing agents (e.g., sodium bicarbonate) increase levels; adjust dosage accordingly.
Vyvanse is a first-line pharmacologic option for ADHD in adults and children 6 years and older, and for moderate to severe BED in adults. It is not recommended for weight loss or obesity. For BED, treatment should be discontinued if no improvement is observed.
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