Vayarin is a "medical food" that can be used in the "clinical dietary management" of children with ADHD.
What Vayarin Is Used For:
Vayarin can be used to treat "certain lipid imbalances associated with ADHD in children." A Vayarin study showed that it reduced classic ADHD symptoms as compared to a placebo, including inattention, hyperactivity, and restlessness and impulsivity.
Vayarin is a prescription strength, proprietary form of omega-3 fatty acids. Other facts include that:
- Vayarin contains phosphatidylserine (PS), EPA, and DHA
- Vayarin is a non-stimulant treatment for ADHD
- the suggested retail cash price for Vayarin is $55
The usual dosage of Vayarin is "2 capsules daily or as directed by a physician." Although there is no official age indication for Vayarin, it was studied on children between 6 and 13 years.
Omega-3's and ADHD:
That ADHD could be treated with omega-3 fatty acids is not a new idea. Dr AJ Richardson published a paper, "Fatty Acids in Dyslexia, Dyspraxia, ADHD and the Autistic Spectrum," in 2001 which suggested that "deficiencies or imbalances in certain highly unsaturated fatty acids (HUFA) of the omega-3 and omega-6 series may contribute to both the predisposition and the developmental expression of dyslexia, dyspraxia, ADHD and autism." And a 2011 meta-analysis of 10 trials in the Journal of the American Academy of Child & Adolescent Psychiatry of "Omega-3 fatty acid supplementation demonstrated a small but significant effect in improving ADHD symptoms." It is also thought that omega-3 fatty acids might help treat people with depression, bipolar disorder, and other psychiatric disorders.
Vayarin Side Effects:
Vayarin was found to be well tolerated without "major adverse events."
What is a Medical Food?:
The FDA states that a medical food is "a food which is formulated to be consumed or administered enterally under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
What You Need To Know:
Although Vayarin has all of the looks of an FDA approved prescription drug, complete with a Prescribing Information Sheet, it is important to keep in mind that it's simply a medical food that does not have to undergo pre-market review or approval by FDA, and does not even have to be registered with the FDA.
Other important information:
Keep in mind that the omega-3 meta-analysis mentioned above suggested that "given the evidence of modest efficacy of omega-3 fatty acid supplementation and its relatively benign side-effect profile, omega-3 fatty acid supplementation, particularly with higher doses of EPA, is a reasonable treatment strategy as augmentation to traditional pharmacotherapy or for those families reticent to use psychopharmacologic agents." So that study didn't suggest using omega-3 treatment by itself in children with significant ADHD symptoms, but instead suggested adding it to another ADHD drug.
Bloch MH, Qawasmi A. Omega-3 fatty acid supplementation for the treatment of children with attention-deficit/hyperactivity disorder symptomatology: systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry 2011;50(10): 991–1000.
FDA. Guidance for Industry: Frequently Asked Questions About Medical Foods. May 1997; Revised May 2007. Accessed May 2013.
Manor I., The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children: A double-blind placebo-controlled trial, followed by an open-label extension. Eur Psychiatry. 2011 Jul 30.
Mischoulon, David. Omega-3 Fatty Acids in Psychiatry. Psychiatric Clinics of North America, Volume 36, Issue 1, March 2013, Pages 15-23.
Vayarin Prescribing Information Sheet. Rev. 7/12.