Japanese Taisho Vorzzz Tablets (Vornorexant, Borzi) Sleep Aid Tablets 2.5mg, 5mg, 10mg: 100 Tablets—Original Research Formula for Improved Sleep

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. For new prescriptions, the maximum dosage until the end of October 2026 is limited to a 14-day supply per prescription.

Bornolexant is OX₁and OX₂Receptor Antagonists (K_i (0.460 and 0.374 nmol/L, respectively). Blocking the binding of the arousal-promoting neuropeptides orexin A and B to their receptors induces a transition from wakefulness to sleep. In rats, this results in a shortened sleep latency and increased REM and non-REM sleep.

2.5 mg: Uncoated tablet, white, identification code T1, diameter/thickness approximately 5.5/2.7 mm, weight approximately 70 mg
5 mg: Score-lined tablet, white, identification code T2, approximately 7 × 3.3 mm, approximately 140 mg
10 mg: Uncoated tablet, pale yellow, identification code T3, approximately 7 × 3.3 mm, approximately 140 mg

Identification Chart:

3.1　Each tablet contains 2.5, 5, or 10 mg of bornorexant (as hydrate).

Excipients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl starch, magnesium stearate; 10 mg also contains yellow iron(III) oxide.

19. Molecular formula C₂₃H₂₂FN₇O₂・1/4H₂O Molecular weight 451.97; melting point 143.2°C. White powder; slightly soluble in ethanol (99.5); practically insoluble in water.

Insomnia

The usual adult dose of Bornolexant 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 Side effects such as drowsiness may increase when the dose exceeds the standard increment; administration should be approached with caution following careful observation, and the dose should be reduced as much as possible once symptoms improve.
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 (as this may delay the onset of sleep).
4. 7.4 When used concomitantly with a moderate CYP3A inhibitor, the dose should be adjusted to 2.5 mg once daily.
5. 7.5 For moderate hepatic impairment (Child-Pugh B), the dosage should be adjusted to 2.5 mg once daily.
6. 7.6 The efficacy and safety of this medication when used in combination with other insomnia treatments have not yet been established.

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

22. 2.5/5/10 mg, 100 tablets per PTP [10 tablets × 10]

24. Meiji Seika Pharma Co., Ltd. Medication Consultation Desk Toll-Free: 0120-093-396 Phone: 03-3273-3539

25. For new drugs, administration is limited to 14 days per course through the end of October 2026.

26. Manufactured and Sold by: Taisho Pharmaceutical Co., Ltd. / Distributed by: Meiji Seika Pharma Co., Ltd.