FDA label
What is Belsomra used for?
Belsomra contains suvorexant. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.”
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Belsomra, tablet, film coated
Indications and Usage, quoted from the label by Merck Sharp & Dohme LLC (NDA204569). Cross-references to other label sections are left out.
BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Source: DailyMed label, set id e5b72731-1acb-45b7-9c13-290ad12d3951, version 21, effective March 10, 2025. NDC 0006-0005, one of 4 listings for this product.
Questions
What is Belsomra used for?
The FDA label says: “BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.”
What drug class is Belsomra?
FDA lists suvorexant in the Orexin Receptor Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Belsomra
- Is Belsomra a controlled substance?Schedule IV
- Generic for BelsomraFDA Orange Book
- Is Suvorexant a controlled substance?Schedule IV
- Orexin Receptor Antagonists listFDA drug class
- NDC 0006-0005Belsomra NDC record
- NDC 0006-0033Belsomra NDC record
- NDC 0006-0325Belsomra NDC record
- Schedule IV drugs listDEA schedule