ORZEYFUL Tablet Ref.[116888] Active ingredients: Oveporexton

2.1 Important Administration Instructions

Administer ORZEYFUL tablets at approximately the same time each day [see Dosage and Administration (2.4)].

Swallow ORZEYFUL tablets whole with water. Do not split, crush or chew tablets. ORZEYFUL may be taken with or without food [see Clinical Pharmacology (12.3)].

2.2 Recommended Dosage and Administration

The recommended dosage of ORZEYFUL is either:

• Take 1 mg orally after awakening and then take 1 mg three to five hours later, OR
• Take 2 mg orally after awakening and then take 2 mg three to five hours later.

The maximum recommended total dosage of ORZEYFUL is 4 mg orally per day.

2.3 Dosage Modifications for CYP3A Inhibitors

ORZEYFUL is contraindicated in patients taking strong CYP3A inhibitors.

If ORZEYFUL is used concomitantly with moderate CYP3A inhibitors, reduce the ORZEYFUL dosage to 0.5 mg orally after awakening and then 0.5 mg three to five hours later (maximum recommended total dosage is 1 mg per day) [see Drug Interactions (7) and Clinical Pharmacology (12.3)].

2.4 Recommendations Regarding Missed Doses

If a scheduled ORZEYFUL dose is missed, take the next dose at the next scheduled time. Do not take two doses at the same time.

There is no specific antidote for an overdose of ORZEYFUL. Treatment should be symptomatic and supportive. If an overdose of ORZEYFUL occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.