Name: Shionogi Quviviq Dali Leisheng Quviviq Tablets for Restful Sleep and Sleep Aid, 25 mg, 50 mg: 100 tablets, Original Japanese Product, Dawei Mian, Improves Sleep
SKU: 3746
Price: 830 HKD
Availability: InStock

描述

Direct overseas shipping (Direct shipping from Japan)

Dali Leisheng Cubic Tablets
QUVIVIQ® Tablets
25 mg / 50 mg

Package Insert No. 1190033F1028_1_03 | Company Code 150923
Revised in December 2024 (3rd Edition) / Revised in December 2025 (4th Edition)

Appetite-Suppressing Receptor Antagonist | Insomnia Treatment | Daridrexant Hydrochloride

Product Details / Approvals, etc.

Japan Standard Commodity Classification Code	87119
Pharmacological Classification Name	Appetite-suppressing receptor antagonists —Medications for Insomnia—
General Name	Dalidrexant Hydrochloride Preparations Daridorexant Hydrochloride
25mg	QUVIVIQ Tablets 25 mg Kubibikkijō YJ 1190033F1028 Approval 30600AMX00253000 Sales Begin December 2024
50mg	QUVIVIQ Tablets 50 mg Kubibikkijō YJ 1190033F2024 Approved 30600AMX00254000 Sales Begin December 2024
Storage Instructions / Expiration Date	Store at room temperature / 3 years
Regulatory Classification	–
Manufacturing and Sales Yuan	Nexera Pharma Japan Co., Ltd. 9-7-2 Akasaka, Minato Ward, Tokyo
Sales Yuan	Shionogi & Co., Ltd. 1-8, 3-chome, Dosho-machi, Chuo Ward, Osaka City
Packaging	25 mg/50 mg, 100 tablets each (10 PTP blisters × 10)
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—May be habit-forming. Use only as prescribed by a doctor or other qualified healthcare professional. Once opened, store the aluminum foil pillow pouch in a dry place.

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

Dalidrexant is a dual orexin receptor antagonist that inhibits the activity of orexin neuropeptides at OX1R and OX2R. In vitro, the apparent equilibrium dissociation constants for human OX1R and OX2R are 0.47 nM and 0.93 nM, respectively. In rats and dogs, an increase in non-REM and REM sleep duration was observed; in rats, the time to first sleep onset was dose-dependently shortened without altering sleep architecture.

3. Specifications and Properties (3.2)

25 mg: Film-coated tablet, light purple to purple, identification mark on the surface: 25; on the back: i; height/thickness/weight: 7 mm/4 mm/0.155 g
50 mg: Film-coated tablet, light orange to orange in color; marking: 50 on the surface, “i” on the inside; height/thickness/weight: 7 mm/4 mm/0.155 g

4. Ingredient Information (3.1/19.)

3.1　Each tablet contains 27.02 mg of darlidrexant hydrochloride (equivalent to 25 mg of darlidrexant) / 54.04 mg (equivalent to 50 mg of darlidrexant).

Excipients: D-mannitol, crystalline cellulose, polyvinylpyrrolidone, cross-linked sodium carboxymethylcellulose, hydrated silica, magnesium stearate, hydroxypropyl methylcellulose, glycerin, talc, titanium dioxide, black iron oxide, iron(III) oxide; the 50 mg dosage also contains yellow iron(III) oxide.

19. Molecular formula C₂₃H₂₃ClN₆O₂・HCl, molecular weight 487.38. White to pale yellow powder.

Structural Formula

5. Indications and Usage (4.)

Insomnia

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

The usual adult dose of Darlidrexant is 50 mg taken orally once daily immediately before bedtime. Depending on the patient’s condition, the dose may be adjusted to 25 mg once daily.

7.1 Take this medication immediately before bedtime. Do not take it if you are likely to get up and be active during the night.
7.2 Avoid taking this medication with meals or immediately after a meal (initial plasma concentrations may be lower after a meal than when taken on an empty stomach).
7.3 In patients with moderate hepatic impairment (Child-Pugh B), the dose should be adjusted to 25 mg once daily; administer with caution.
7.4 When used concomitantly with a moderate CYP3A inhibitor, determine whether administration is appropriate based on clinical observation; if administered, the dosage should be adjusted to 25 mg once daily.
7.5 The efficacy and safety of concomitant use with other insomnia medications have not yet been established.

7. Important Notes (8., 9., 11., 20.)

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. Narcolepsy or cataplexy may worsen. No studies have been conducted in patients with moderate-to-severe respiratory impairment (excluding OSA and mild-to-moderate COPD). The effects on patients with organic brain disorders may be more pronounced. Contraindicated in patients with severe hepatic impairment. Should be administered to pregnant women only if the benefits outweigh the risks.

11. Common side effects in Japanese patients in Phase 3: drowsiness (25 mg: 3.71 TP3T; 50 mg: 6.81 TP3T), floating vertigo (50 mg: 1.91 TP3T).

20. After opening the aluminum foil pillow pouch, store it in a dry place.

Plasma concentrations of dalidrexant (non-elderly/elderly):

PK fig07

PK fig08

Driving simulation: 9 hours after the first dose of 50 mg, the upper limit of the difference between SDLP and placebo exceeded the threshold of 2.6 cm; on Day 4, however, it was below the threshold. The approved dose is up to 50 mg.

8. Contraindications (2.)

2.1 Patients with a history of allergy to any of the ingredients in this product
2.2 Patients with severe hepatic impairment (Child-Pugh Class C)
2.3 Patients currently taking itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir-containing formulations, cobicistat-containing formulations, ceritinib, or ensitrelvir fumarate

21–26. Other Official Information

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

22. 25 mg/50 mg, 100 tablets each (10 PTP blisters × 10)

24. Shionogi & Co., Ltd. Medical Information Center Phone: 0120-956-734 med.shionogi.co.jp

26. Manufacturer and Distributor: Nexera Pharma Japan Co., Ltd. / Distributor: Shionogi & Co., Ltd.

※ This page was translated by Hkeemall based on PMDA Package Insert 1190033F1028_1_03; it is not a substitute for a doctor’s prescription or the original Japanese version.
Enter "Cubivic" in the PMDA "Package Insert Information" field to search for the original version.

[Disclaimer]

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.
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.
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	Shionogi Dali Leisheng Cubic Tablets 25 mg, Shionogi Dali Leisheng Cubic Tablets 50 mg

1 review for 日本鹽野義 Quviviq 達利雷生クービビック錠安眠助眠片25mg 50mg ：100錠日本原裝達衛眠改善睡眠

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Rated 4.00 out of 5 based on 1 customer rating

Average of 1 review

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Rated 4 out of 5

Mabel Li – August 27, 2026

I used to have very light sleep no matter how long I slept. After taking it, my deep sleep increased, I feel refreshed when waking up, and I don't feel any sense of dependency.