DAYVIGO FILM-COATED TABLET 10MG

INDICATION(S)

DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

CONTRAINDICATIONS

(DAYVIGO is contraindicated in the following patients)

1. Patients with narcolepsy.
2. Patients with a history of hypersensitivity to the ingredients of this product.
3. Patients with severe hepatic function disorder (plasma lemborexant concentration may increase) (see “PHARMACOKINETICS” section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DOSAGE AND ADMINISTRATION

The usual dosage for adults is 5 mg of lemborexant administered orally once daily immediately before bedtime, with at least 7 hours remaining before the planned time of awakening. The dosage may be adjusted as appropriate according to clinical response and tolerability, but should not exceed 10 mg once daily.

Precautions regarding dosage and administration

1. If dosage should be increased beyond the starting dosage due to insufficient effect, the dose should be increased to 10 mg once daily. Dose escalation beyond the starting dose should be performed with care while closely observing the condition of the patient, as adverse reactions such as somnolence may increase, and dose reduction should be attempted as symptoms improve.

2. Instruct the patient to take DAYVIGO immediately before bedtime. Instruct the patient not to take DAYVIGO if less than 7 hours before the time of planned awakening is possible.

3. Since sleep induction may be delayed, avoid taking DAYVIGO at the same time or right after meals. (With postprandial administration, the plasma lemborexant concentration immediately after the administration may decrease compared to that with administration on an empty stomach.) (see “PHARMACOKINETICS” section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

4. Concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors is contraindicated. The maximum recommended dosage of DAYVIGO is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors. (see “PHARMACOKINETICS” section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

5. Since plasma lemborexant concentration increase in patients with moderate hepatic function disorder, the dosage may not exceed 5 mg once daily in these patients and should be administered with care. (see “PRECAUTIONS” and “PHARMACOKINETICS” sections – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

6. The efficacy and safety of concomitant use with other drugs for treatment of insomnia have not been established.