What is the recommended use and dosage of lisdexamfetamine (LDX) dimesylate for attention deficit hyperactivity disorder (ADHD) and binge eating disorder?

Lisdexamfetamine Dimesylate: Recommended Use and Dosage for ADHD and Binge Eating Disorder

Lisdexamfetamine dimesylate (LDX) is indicated for the treatment of ADHD in adults and children 6 years and older, and for moderate to severe binge eating disorder (BED) in adults, with specific dosing protocols for each condition. 1

Indications

ADHD Treatment

• LDX is FDA-approved for treating ADHD in adults and pediatric patients 6 years and older 1
• LDX is typically considered a second-line therapy in many European countries, while it may be used as a first-line option in the United States 2
• If methylphenidate treatment fails to provide adequate benefit after appropriate dosing and duration, LDX should be considered as the next option before non-stimulants 2
• In Japan, LDX is approved as a third-line treatment option after trials of OROS-MPH, atomoxetine, or guanfacine extended release 2

Binge Eating Disorder Treatment

• LDX is indicated for moderate to severe binge eating disorder (BED) in adults 1
• For adults with BED who prefer medication or have not responded to psychotherapy alone, LDX is suggested as a treatment option 2
• LDX has demonstrated efficacy in reducing binge eating days per week and achieving binge eating cessation in adults with moderate to severe BED 3

Dosing Guidelines

ADHD Dosing

• Initial titration typically starts at 30 mg once daily in the morning 1
• Dose can be adjusted in 20 mg increments at weekly intervals 1
• Target doses range from 30-70 mg once daily based on response and tolerability 1
• Maintenance treatment has demonstrated efficacy in preventing relapse in both pediatric and adult populations 1

Binge Eating Disorder Dosing

• For BED, dosing follows a similar pattern to ADHD treatment 4
• Initial titration starts at 30 mg once daily 4
• Target doses are typically 50-70 mg once daily 4
• Long-term treatment (up to 12 months) has demonstrated continued safety and tolerability 4

Efficacy

ADHD Efficacy

• LDX has demonstrated significant improvements in ADHD symptoms compared to placebo in both pediatric and adult populations 1
• Efficacy has been shown to last up to 14 hours post-dose in adults, providing extended symptom control throughout the day 5
• Maintenance treatment significantly reduces treatment failure rates (15.8% with LDX vs. 67.5% with placebo) 1

Binge Eating Disorder Efficacy

• At doses of 50-70 mg/day, LDX significantly reduces binge eating days per week compared to placebo 3
• 4-week binge eating cessation was achieved in 42.2% of patients at 50 mg/day and 50% at 70 mg/day, compared to 21.3% with placebo 3
• Efficacy for BED appears dose-dependent, with 50 mg and 70 mg doses showing significant improvement while 30 mg did not differ significantly from placebo 3

Safety Considerations

• Common adverse effects include dry mouth (27.2%), headache (13.2%), insomnia (12.4%), and upper respiratory tract infections (11.4%) 4
• LDX treatment is associated with increases in blood pressure and heart rate, requiring monitoring 4
• Weight loss is a common effect, with mean reductions of 4.3 kg observed in clinical trials for BED 3
• LDX is not indicated or recommended for weight loss, as use of sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events 1
• Pediatric patients with ADHD younger than 6 years experienced more long-term weight loss than patients 6 years and older, limiting its use in very young children 1

Important Clinical Considerations

• Once-daily dosing of LDX should be preferred to improve medication adherence 2
• LDX is a prodrug that requires enzymatic conversion primarily by red blood cells to release active d-amphetamine, providing gradual onset and extended duration of action 5
• Regular monitoring of vital signs, weight, and potential psychiatric adverse effects is essential during treatment 4
• LDX should be used as part of a comprehensive treatment approach that may include behavioral interventions, especially for ADHD 6
• Regional variations in guidelines exist, with Western countries more likely to use stimulants as first-line therapy while some Asian countries prefer non-stimulants initially 2