To evaluate the sedative and physiological effects of alfaxalone intramuscular (IM) administration, 12 healthy cynomolgus monkeys were administered single IM doses of alfaxalone
at 0.625 mg/kg (ALFX0.625), 1.25 mg/kg (ALFX1.25), 2.5 mg/kg (ALFX2.5), 5 mg/kg (ALFX5), 7.5 mg/kg (ALFX7.5), or 10 mg/kg (ALFX10); saline was used as the control (CONT). The
sedative effects were subjectively evaluated using a composite measure scoring system in six animals. Changes in respiratory rate, pulse rate, non-invasive blood pressure,
percutaneous oxygen-hemoglobin saturation (SpO
2
), and rectal temperature were observed after IM treatments in the other six animals. All animals were allowed to lay down
following the ALFX5, ALFX7.5, and ALFX10 treatments, whereas lateral recumbency was achieved in only two animals after ALFX2.5 treatment and none after the CONT, ALFX 0.625, and
ALFX1.25 treatments. The median time (interquartile range) to lateral recumbency was 6.5 min (5.3–7.8), 4.0 min (4.0–4.0), and 3.0 min (3.0–3.8), and the duration of immobilization
was 27.5 min (19.0–33.8), 56.0 min (42.3–60.8), and 74.5 min (62.8–78.0) after the ALFX5, ALFX7.5, and ALFX10 treatments, respectively. Endotracheal intubation was achieved in all
six animals after the ALFX7.5 and ALFX10 treatments. Dose-dependent decreases in respiratory rate, non-invasive blood pressure, SpO
2
, and rectal temperature were
observed, and the quality of recovery was smooth in all animals after the ALFX5, ALFX7.5, and ALFX10 treatments. Thus, alfaxalone IM induced a dose-dependent sedative effect in
cynomolgus monkeys, but at higher doses, hypotension, hypoxemia, and hypothermia could be induced.