From the Guidelines
Aripiprazole (Abilify) is approved by the FDA for the treatment of irritability associated with autism spectrum disorder (ASD) in children and adolescents aged 6-17 years, with a recommended dose of 5-15 mg/day 1.
On-Label Indications
The on-label indication for Aripiprazole in ASD includes:
- Irritability
- Hyperactivity
- Stereotypy
- Social withdrawal
- Inappropriate speech with a fixed dose of 5,10, or 15 mg/d 1.
Off-Label Indications
Off-label uses for Abilify in autism may include treatment of co-occurring conditions such as:
- Attention deficit hyperactivity disorder (ADHD)
- Anxiety
- Obsessive-compulsive behaviors However, these uses should be approached with caution and under close medical supervision due to limited evidence and potential side effects 1.
Treatment Considerations
In general, Abilify should be used at the lowest effective dose and for the shortest duration necessary to achieve treatment goals, with regular monitoring for side effects such as:
- Weight gain
- Metabolic changes
- Extrapyramidal symptoms Combining medication with parent training is moderately more efficacious than medication alone for decreasing serious behavioral disturbance and modestly more efficacious for adaptive functioning 1.
From the Research
On-Label Indications for Aripiprazole in Autism Spectrum Disorder (ASD)
- Aripiprazole is approved for the treatment of irritability associated with autistic disorder in children and adolescents (6-17 years) 2, 3, 4, 5
- The medication has been shown to be effective in reducing symptoms of irritability, aggression, and self-injurious behavior in individuals with ASD 2, 3, 4, 5
Off-Label Indications for Aripiprazole in Autism Spectrum Disorder (ASD)
- While there is limited evidence to support the use of aripiprazole for off-label indications in ASD, some studies suggest that it may be effective in reducing symptoms of hyperactivity and stereotypy in individuals with ASD 3, 5
- Aripiprazole may also be used off-label to treat co-occurring conditions such as attention deficit hyperactivity disorder (ADHD) in individuals with ASD, although the evidence for this is limited 6
Efficacy and Safety of Aripiprazole in ASD
- Aripiprazole has been shown to be generally safe and well-tolerated in the treatment of irritability associated with ASD in children and adolescents 2, 3, 4, 5, 6
- Common adverse events associated with aripiprazole use in ASD include somnolence, weight gain, and extrapyramidal symptoms such as tremor and drooling 3, 5, 6
- Long-term studies have shown that aripiprazole can be effective and well-tolerated for up to 52 weeks in the treatment of irritability associated with ASD in children and adolescents 6