Viloxazine Plus Caffeine Increases Insomnia Likelihood in Adults With ADHD

Using viloxazine extended-release (ER) capsules with caffeine among adults significantly increases the likelihood of insomnia, but may not increase the likelihood of experiencing other caffeine-related adverse events (AEs), according to study results presented at Psych Congress 2022, held from September 17 to 20, 2022, in New Orleans, Louisiana.

Researchers sought to analyze the potential safety impact of caffeine consumption with viloxazine ER in adults with attention-deficit/hyperactivity disorder (ADHD). They evaluated data from a phase 3 placebo-controlled, double-blind (DB) trial and ongoing open-label extension (OLE) in adults with ADHD who consumed caffeine.

A total 372 participants received either viloxazine ER (n=189) or placebo (n=183). Approximately 85% (n=316) of the study participants self-reported caffeine use (viloxazine ER 859 mg/week; placebo 1034 mg/week) during the trial. Treatment-emergent adverse events were reported by almost 50% of participants receiving placebo. Treatment-emergent adverse events were reported by 60% of participants who received viloxazine ER.

A logistic regression model was used to estimate the probability that a caffeine-related AE occurred as a function of viloxazine ER dose and caffeine consumption. The researchers found that participants in the DB placebo group (n=44), DB viloxazine ER group (n=79), and OLE viloxazine ER group (n=33) reported caffeine-associated AEs. They noted that insomnia-related, fatigue, nausea, headache-related, decreased appetite, and somnolence-related terms occurred in 5% or more of participants in the DB viloxazine ER group.

They reported that the probability of experiencing insomnia-related AEs was significantly increased with caffeine consumption (P =.02), and that caffeine consumption did not significantly increase with any other AE.

Study authors conclude, “This analysis suggests using caffeine with viloxazine ER did not increase the likelihood of experiencing caffeine-related AEs, except for insomnia.”

Disclosure: This research was supported by Supernus Pharmaceuticals Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.