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Eisai Japan Dayvigo Lemborexant (Lemborexant) Dayvigo Tablets: Sleep Aid, Sleep Inducer, 2.5 mg, 5 mg, 10 mg: 100 tablets Sleep Inducer, Treatment for Insomnia

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HKD$620.00 – HKD$1,080.00Price range: HKD$620.00 through HKD$1,080.00
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描述

Direct overseas shipping (Direct shipping from Japan)

Lai Bo Lei Sheng Deebigo Tablets
Dayvigo® Tablets
2.5 mg / 5 mg / 10 mg

Package Insert No. 1190027F1022_1_08 | Company Code 170033
Revised in December 2024 (3rd Edition) / Revised in December 2025 (4th Edition)

Medications for Insomnia | Lemborexant | Orcinol Receptor Antagonist | Improves Sleep | Difficulty Falling Asleep | Helps You Fall Asleep

Dayvigo (Lemborexant) Deebigo Tablets

Product Details / Approvals, etc.

Japan Standard Commodity Classification Code 87119
Pharmacological Classification Name Medications for Insomnia
General Name Lemborexant Formulation
Lemborexant
2.5mg Dayvigo Tablets 2.5 mg
YJ 1190027F1022
Approved 30200AMX00017000
Sales Begin July 2020
Valid for 5 years
5mg Dayvigo Tablets 5 mg
YJ 1190027F2029
Approved 30200AMX00018000
Sales Begin July 2020
Valid for 4 years
10mg Dayvigo Tablets 10 mg
YJ 1190027F3025
Approved 30200AMX00019000
Sales Begin July 2020
Valid for 4 years
Storage Methods Store at room temperature
Regulatory Classification –
Manufacturing and Sales Yuan Eisai Co., Ltd.
4-6-10 Koishikawa, Bunkyo Ward, Tokyo
Packaging 2.5 mg: 100 tablets in PTP blisters / 100-tablet bottle
5 mg: 100 tablets (PTP) / 100-tablet bottle / 500 tablets (PTP)
10 mg: 100 tablets, PTP
Shipping method Direct overseas shipping (Direct shipping from Japan)
※Prescription drugs and controlled substances must comply with local regulations.
Preparation and shipping time Once payment and prescription eligibility have been verified, orders are typically shipped within 4 to 7 business days.

1. Product hint

Conditions for Approval: A drug risk management plan must be developed and properly implemented. Caution—Habit-forming. Must be used only with a prescription from a physician or other qualified healthcare professional.

2. Product Characteristics and Mechanism of Action (18.)

Lemborexant in Humans OX1/OX2 The receptor Ki values were 8.1 and 0.48 nmol/L, respectively. Reversible inhibition of orexin A/B binding to receptors induces a transition from wakefulness to sleep in the brain. In rats, this resulted in a shortened sleep latency and increased total sleep time, with no significant change in the REM sleep percentage. The binding of the metabolite M10 is comparable to that of the parent compound.

3. Specifications and Properties (3.2)

All strengths are film-coated tablets measuring 7.1 mm in diameter, 3.3 mm in thickness, and weighing 127 mg.
2.5 mg: Light red, labeled LЄM 2.5
5 mg: Slightly yellow; identification: LЄM 5
10 mg: Orange, marked LЄM 10

4. Ingredient Information (3.1/19.)

3.1 Each tablet contains 2.5, 5, or 10 mg of lemborexant.

Common Excipients: Titanium Dioxide, Magnesium Stearate, Talc, Low-Substituted Hydroxypropyl Cellulose, Lactose Monohydrate, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellulose, Macrogol 6000. The 2.5 mg dose contains iron(III) oxide; the 5 mg dose contains yellow iron(III) oxide; the 10 mg dose contains yellow iron(III) oxide and iron(III) oxide.

19. Molecular formula C22H20F2N4O2 Molecular weight: 410.42; melting point: 177°C; logP = 3.7.

Structural Formula

5. Indications and Usage (4.)

Insomnia

6. Dosage and Administration (6./7.)

The usual adult dose of lemborexant is 5 mg taken orally once daily immediately before bedtime. The dose may be adjusted based on symptoms, but should not exceed 10 mg once daily.

  1. 7.1 If the dose is insufficient and an increase is necessary, the maximum dose is 10 mg once daily; an increased risk of drowsiness and other side effects may occur with higher doses, so administration should be approached with caution following careful observation, and the dose should be reduced as much as possible once the condition improves.
  2. 7.2 Take this medication immediately before bedtime. Do not take it if you are likely to get up and be active during the night.
  3. 7.3 Avoid taking this medication with meals or immediately after a meal.
  4. 7.4 When used concomitantly with moderate- or strong-potency CYP3A inhibitors (such as fluconazole, erythromycin, verapamil, itraconazole, clarithromycin, etc.), the decision to administer the drug should be made after observation; if used concomitantly, the dosage should be adjusted to 2.5 mg once daily.
  5. 7.5 In patients with moderate hepatic impairment, do not exceed 5 mg once daily; use with caution.
  6. 7.6 The efficacy and safety of this medication when used in combination with other insomnia treatments have not yet been established.

7. Important Notes (8./9./11.)

8. The effects may persist until the morning after dosing, causing drowsiness and impaired attention, concentration, and reflexes. Do not operate dangerous machinery or drive. Once symptoms improve, reassess whether to continue treatment; do not administer the medication indiscriminately.

9. Hypersomnia or sudden collapse may worsen. The effects of organic brain disorders may be more pronounced. Contraindicated in patients with severe hepatic impairment. There is insufficient experience with the use of this medication in patients with moderate to severe respiratory impairment (excluding OSA and COPD).

11. The main side effects include drowsiness. Approximately 4 hours after administration, increased unsteadiness may be observed; at a dose of 10 mg, decreased attention and memory may occur.

Plasma concentrations of remborexant:

PK

8. Contraindications (2.)

  1. 2.1 Patients with a history of allergy to any of the ingredients in this product
  2. 2.2 Patients with severe hepatic impairment [may result in increased plasma concentrations of lembolixant.]

21–26. Other Official Information

21. A drug risk management plan must be developed and implemented.

22. 2.5 mg: 100 tablets in PTP blisters / 100-tablet bottle; 5 mg: 100 tablets in PTP blisters / 100-tablet bottle / 500 tablets in PTP blisters; 10 mg: 100 tablets in PTP blisters

24. Eisai Co., Ltd. hhc Hotline Toll-Free Number 0120-419-497

26. Manufacturer and Distributor: Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo

※ This page was translated by Hkeemall based on PMDA Package Insert 1190027F1022_1_08; it is not a substitute for a doctor’s prescription or the original Japanese version.
Enter "Deebigo" in the PMDA "Package Insert Information" search field to view the original version.

[Disclaimer]

  1. The information regarding medications, treatments, or health management contained in this article is compiled from international authoritative medical journals and official clinical literature, and is intended for general science and educational reference only.
  2. The indications, side effects, and contraindications of related medications may vary depending on national regulations and individual physical conditions. Do not blindly take medication on your own or change your treatment plan.
  3. The author and publishing platform assume no legal liability for any medical delays, adverse reactions, or direct or indirect losses caused by the use of the information in this article. All medical decisions should be discussed with your attending physician before being made.

Additional information

Specifications

Eisai Deebigo Tablets 2.5 mg, Eisai Deebigo Tablets 5 mg, Eisai Deebigo Tablets 10 mg

1 review for 日本衛材 Dayvigo 萊博雷生 Lemborexant デエビゴ錠 安眠 助眠片 2.5mg 5mg 10mg:100錠 睡眠導入劑 治療失眠

5.00

Average of 1 review

  1. Kiuby Siu –

    I've been taking it for a while, I sleep very soundly, and the next day I wake up without a heavy head. It really helps.

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