Dose-dependent changes in immune cell counts and immune organ weight/morphology, most prominent in rats
“Concerning the immune system, dose-dependent effects of solriamfetol on numbers of immune cells and morphology/weight of immune-system related organs (most prominent in rat studies) were observed.”
Extensive distribution into pigmented and non-pigmented tissues, including brain
“After oral administration, solriamfetol was extensively distributed into pigmented and non-pigmented tissues, including the brain.”
✓ VerifiedFDA pharmacology/toxicology review, p. 10Source ↗
Modality-specific risk
Stimulant-like CNS toxicity, the most prominent effect across species
“In nonclinical toxicology studies in the mouse, rat, dog, and rabbit, the most prominent drug-related effects of solriamfetol are observed in the CNS, most likely due to its stimulant-like pharmacology.”
✓ VerifiedFDA pharmacology/toxicology review, p. 11Source ↗