What this pack is
BELSOMRA is the brand name in this record; suvorexant is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
Suvorexant is a dual orexin-receptor antagonist that binds OX1R and OX2R and suppresses wake-promoting orexin signalling. In plain language, it does not ‘switch off’ all brain activity; it reduces one wake-maintaining signal. This mechanism cannot predict individual suitability, strength choice or safe combination with another sleep or sedative medicine.
Read source: United States ↗Current regulatory record · reviewed 2026-08-30More about its action and precautions →A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
BELSOMRA is the brand name in this record; suvorexant is the generic name. Read both together with the dosage form (oral tablet).
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
PRODUCT PRESENTATION IDENTITY
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed public label (SPL v21; updated 10 Mar 2025)
United States label · Current U.S. DailyMed public label (SPL v21; updated 10 Mar 2025)
United States label · Current U.S. DailyMed public label (SPL v21; updated 10 Mar 2025)
United States label · Current U.S. DailyMed public label (SPL v21; updated 10 Mar 2025)
JP · Current Japanese PMDA electronic label (revised Mar 2026; verified 30 Aug 2026)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
JP · Current Japanese PMDA electronic label (revised Mar 2026; verified 30 Aug 2026)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
JP · Current Japanese PMDA electronic label (revised Mar 2026; verified 30 Aug 2026)
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
PUBLIC LABEL IMAGE
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The 5, 10, 15 and 20 mg figures are labelled suvorexant amounts per tablet, not a personal regimen supplied by this site. Older adults and people also using sleep medicines, sedatives, opioids, alcohol or CYP3A-related medicines particularly need professional review of the full medicine list and actual pack.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Use this card to organise questions about BELSOMRA (suvorexant). Keep the exact pack, its current label and the full medicine list together.
BELSOMRA is the brand in this record and suvorexant is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
HOW IT WORKS · NOT A TREATMENT PLAN
SOURCE EVIDENCE REGISTER
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
SOURCE-TRACEABLE ARCHIVE
This page includes an exact current U.S. public-label package panel for BELSOMRA, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
FDA approved BELSOMRA suvorexant 5, 10, 15 and 20 mg oral tablets. Approval history does not establish current local stock or individual suitability.
FDA: BELSOMRA (suvorexant) NDA 204569 original approval letter (13 Aug 2014) ↗The current PMDA label records approval and launch milestones for the Japanese 15 mg and 20 mg products; this page does not turn them into an age-based tablet count.
Japan PMDA: current professional product records, electronic label, patient guide and safety-information access for BELSOMRA 10/15/20 mg ↗The current PMDA label records the later 10 mg product; market strength differences are not a basis for self-conversion.
Japan PMDA: current professional product records, electronic label, patient guide and safety-information access for BELSOMRA 10/15/20 mg ↗SPL v21 displays four 30-tablet blister cartons and a Medication Guide, retaining C-IV, next-day impairment and complex-sleep-behaviour boundaries.
DailyMed (NLM): current U.S. BELSOMRA suvorexant oral-tablet public label, Medication Guide and four 30-tablet blister-carton panels (SPL v21; updated 10 Mar 2025) ↗MARKET SCOPE
The page displays official label panels for four 30-tablet cartons. Label presence does not establish local stock, insurance coverage, purchase eligibility or individual suitability.
This review retains PMDA product identities and tablet-appearance text but did not obtain an official principal display panel matched one-to-one to a Japanese pack, so no U.S. carton or retail image is substituted.
No local approval, supply, pack, prescription eligibility or originator/generic relationship is inferred from U.S. or Japanese records.
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
It is a dual orexin-receptor antagonist with a different mechanism from some other sleep medicines, but it can still cause next-day drowsiness, complex sleep behaviours, falls and interactions. A different mechanism does not mean safer or suitable for everyone.
Do not choose from age or pack numbers. Market label, full medicine list, liver function, breathing status, fall risk and other medicines can affect professional decisions; have the prescriber review the actual pack and all medicines.
Do not self-add, split, make up or combine tablets. A score or pack mg is not permission to change use; added CNS depression may increase next-day impairment, falls, complex sleep behaviours or breathing risk.
Alcohol should not be used as a sleep combination. It can add drowsiness, impaired coordination, memory problems and falls; disclose actual alcohol use for professional review.
READ NEXT
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.