DAYVIGO FILM-COATED TABLET 10MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Lemborexant

Available from:

EISAI (SINGAPORE) PTE. LTD.

ATC code:

N.A

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Lemborexant 10 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Eisai Manufacturing Limited

Authorization status:

ACTIVE

Authorization date:

2021-09-15

Summary of Product characteristics

DAYVIGO®
Film-Coated Tablet 5mg, 10mg

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)
DESCRIPTION
1.
COMPOSITION
5 mg tablets: Each pale-yellow film-coated tablet contains 5 mg of
lemborexant. Yellow ferric oxide, titanium oxide, magnesium
stearate, talc, low substituted hydroxypropylcellulose, lactose
hydrate, hydroxypropylcellulose, hypromellose, and macrogol 6000
are also present as inactive ingredients.
10 mg tablets: Each orange film-coated tablet contains 10 mg of
lemborexant. Yellow ferric oxide, red ferric oxide, titanium oxide,
magnesium stearate, talc, low substituted hydroxypropylcellulose,
lactose hydrate, hydroxypropylcellulose, hypromellose, and
macrogol 6000 are also present as inactive ingredients.
2.
PRODUCT DESCRIPTION
Brand name
Formulation /
Identification code
Appearance
Description
Top
Bottom
Side
DAYVIGO Tablet 5mg
film-coated tablets
pale yellow
LЄM
5
Diameter / Mass / Thickness
7.1 mm / 127 mg / 3.3 mm
DAYVIGO Tablet 10mg
film-coated tablets
orange
LЄM
10
Diameter / Mass / Thickness
7.1 mm / 127 mg / 3.3 mm
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.
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.