FDA Approves ADHD Drug for Patients 6 and Older. Parents need to be informed about their kids being misdiagnosed with ADHD. 50% of these kids have sleep apnea. Cure the sleeping problem through your dentist that is certified in sleep disorders.

Neos Therapeutics news release; 2017 Sep 15

October 5, 2017

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Neos Therapeutics, Inc., has announced that the US Food and Drug Administration (FDA) has approved Adzenys ER (amphetamine) extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged ≥6 years. Neos Therapeutics is headquartered in Dallas and Fort Worth, Texas.

Indications: Adzenys ER is a central nervous system (CNS) stimulant indicated for the treatment of ADHD) in patients aged ≥6 years.


Pediatric patients (aged 6 to 17 years):

  • Starting dose is 6.3 mg (5 mL) once daily in the morning.
  • Maximum dose is 18.8 mg (15 mL) for patients 6 to 12 years, and 12.5 mg (10 mL) once daily for patients 13 to 17 years.

Adults: 12.5 mg (10 mL) once daily in the morning.

Adverse reactions:

  • Pediatric patients aged 6 to 12 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever.
  • Pediatric patients aged 13 to 17 years: Adverse reactions included loss of appetite, insomnia, abdominal pain, weight loss, and nervousness.
  • Adults: Adverse reactions included dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections.

This Week’s Must Reads

Must Reads in ADHD