Extended-Release Viloxazine and Caffeine Combined Together May Raise Insomnia Risk

Caffeine use combined with extended-release viloxazine appeared to increase the likelihood of insomnia but no other caffeine-related adverse events in adults with attention-deficit/hyperactivity disorder (ADHD), according to a poster presentation on September 18th at the 35th Annual Psych Congress in New Orleans, Louisiana.

Extended-release viloxazine is approved by the US Food and Drug Administration for the treatment of ADHD in adults and children aged 6 years and older. The novel nonstimulant medication inhibits cytochrome P450-1A2, which is responsible for caffeine metabolism, explained presenter Jami Earnest, PharmD, BCPP, and coauthors.

Related: Adult ADHD Affects Genders Differently, Study Finds

Researchers analyzed data from a phase 3, double-blind, placebo-controlled trial and ongoing open-label extension to gauge whether caffeine consumption affected the safety of extended-release viloxazine. Adults with ADHD in the trial reported their caffeine use at each study visit.

During the trial, approximately 85% of 372 adults reported caffeine use. Participants who received extended-release viloxazine reported a mean 859 mg of caffeine a week compared with 1034 mg a week among those who received placebo, according to the poster.

A total 44 participants who received double-blind placebo, 79 who received double-blind extended-release viloxazine, and 33 who received open-label extension viloxazine reported any caffeine-associated adverse events. Insomnia, fatigue, nausea, headache, decreased appetite, and somnolence occurred in 5% or more of participants treated with extended-release viloxazine.

A logistic regression model that estimated the probability an adverse event occurred as a result of viloxazine dose combined with caffeine found a significantly increased probability for insomnia alone.

“This analysis suggests using caffeine with viloxazine extended-release did not increase the likelihood of experiencing caffeine-related adverse events, except for insomnia,” researchers wrote. “Providers and patients should be aware of the potential for viloxazine extended-release to augment caffeine exposure.”

Supernus Pharmaceuticals Inc. sponsored the study.

Reference

Earnest J, et al. Viloxazine extended-release capsules (Qelbree) for adults with attention-deficit/hyperactivity disorder: evaluating the potential impact of caffeine exposure on safety profile. Poster presented at Psych Congress; September 17-20, 2022; New Orleans, Louisiana.