tasimelteon Side Effects

What the FAERS Data Reveals About tasimelteon Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 5,762 voluntary reports linked to tasimelteon and its brand equivalents (Hetlioz), spanning 2014 through 2025. Of those, 166 (2.9%) listed death as an outcome and 281 (4.9%) involved hospitalization. The most common indication reported alongside adverse events was Non-24-Hour Sleep-Wake Disorder.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 57% were female and 43% male; age distribution skews toward 45-64, with 1,272 reports in that bracket. The single most reported reaction is drug ineffective with 1,635 submissions, followed by insomnia and product dose omission issue.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.