Prescription medicine
Suvorexant Brand names: Belsomra
Suvorexant (Belsomra) is a prescription medicine with an FDA approval on record since 2014. No generic is listed; pharmacies paid $15.21 per Belsomra 10 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- DEA Schedule IV
Check it at the source: the suvorexant FDA label on DailyMed (effective March 10, 2025, Merck Sharp & Dohme LLC); the NDA 204569 record on Drugs@FDA; every suvorexant label on DailyMed.
Highlights of the record
FDA label of March 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBELSOMRA ® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Forms and strengths
- 5 mg
- 10 mg
- 15 mg
- 20 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 13, 2014 Belsomra, Merck Sharp Dohme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 29, 2033 Belsomra tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $15.21 per tablet Belsomra 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2021 0 Class I among all firms' recalls; latest July 21, 2025
- FAERS reports
- 12,888 through July 30, 2026
What is suvorexant used for?
From the label: indications and usageBELSOMRA ® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance ( 1 ).
Conditions named in the indications of suvorexant's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Orexin Receptor Antagonist.
Source: FDA drug label (BELSOMRA), Merck Sharp & Dohme LLC, effective March 10, 2025 (SPL set e5b72731-1acb-45b7-9c13-290ad12d3951), via openFDA; the full label on DailyMed
What does the patient leaflet for suvorexant say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BELSOMRA?BELSOMRA may cause serious side effects including: Decreased awareness and alertness. The morning after you take BELSOMRA, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Do not take more BELSOMRA than prescribed. Do not take BELSOMRA unless you are able to stay in bed a full night (at least 7 hours) before you must be active again. Take BELSOMRA within 30 minutes of going to bed. See " What are the possible side effects of BELSOMRA? " for more information about side effects.
From the patient leaflet: What should I avoid while taking BELSOMRA?Do not drink alcohol while taking BELSOMRA. It can increase your chances of getting serious side effects. Do not drive, operate heavy machinery, do anything dangerous or do other activities that require clear thinking after taking BELSOMRA. You may still feel drowsy the next day after taking BELSOMRA. Do not drive or do other dangerous activities until you feel fully awake.
From the patient leaflet: How should I store BELSOMRA?Store BELSOMRA at room temperature between 68°F to 77°F (20°C to 25°C). Store in the original package until use, to protect from light and moisture. Keep BELSOMRA and all medicines out of reach of children.
Source: FDA drug label (BELSOMRA), Merck Sharp & Dohme LLC, effective March 10, 2025 (SPL set e5b72731-1acb-45b7-9c13-290ad12d3951), via openFDA; the full label on DailyMed
Is there a generic for suvorexant (Belsomra)?
No generic suvorexant is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 4 patents for Belsomra tablets: the compound patent runs to November 20, 2029, and the last listed entry to May 29, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for suvorexant (Belsomra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $15.21 per Belsomra 10 mg tablet, up 2% from $14.85 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Belsomra 15 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Belsomra 10 mg tablet | Brand | $15.21 per tablet | $456.38 | +2% |
| Belsomra 15 mg tablet | Brand | $15.19 per tablet | $455.72 | +2% |
| Belsomra 20 mg tablet | Brand | $15.21 per tablet | $456.16 | +2% |
| Belsomra 5 mg tablet | Brand | $15.20 per tablet | $456.04 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has suvorexant been recalled?
The FDA's Enforcement Report lists 2 recalls naming suvorexant since 2021: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 21, 2025 | Class II | Merck & Co. Inc | Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying … |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the suvorexant label say about other medicines?
The suvorexant label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name suvorexant. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aprepitant | drug interactions | The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
| Atazanavir | drug interactions | The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
| Carbamazepine | drug interactions | CYP3A Inducers Suvorexant exposure can be substantially decreased when co-administered with strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin). |
| Ciprofloxacin | drug interactions | The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
| Clarithromycin | drug interactions | CYP3A Inhibitors Concomitant use of BELSOMRA with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) is not recommended [see Clinical Pharmacology (12.3) ]. |
| Digoxin | drug interactions | Monitor digoxin concentrations ( 7.3 ). |
| Diltiazem | drug interactions | The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
| Erythromycin | drug interactions | The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
| Fluconazole | drug interactions | The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
| Fosamprenavir | drug interactions | The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
| Imatinib | drug interactions | The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
| Itraconazole | drug interactions | CYP3A Inhibitors Concomitant use of BELSOMRA with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) is not recommended [see Clinical Pharmacology (12.3) ]. |
| Ketoconazole | drug interactions | CYP3A Inhibitors Concomitant use of BELSOMRA with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) is not recommended [see Clinical Pharmacology (12.3) ]. |
| Nefazodone | drug interactions | CYP3A Inhibitors Concomitant use of BELSOMRA with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) is not recommended [see Clinical Pharmacology (12.3) ]. |
Every other medicine the suvorexant label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nelfinavir | drug interactions | … itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) is not recommended [see Clinical … |
| Phenytoin | drug interactions | CYP3A Inducers Suvorexant exposure can be substantially decreased when co-administered with strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin). |
| Posaconazole | drug interactions | CYP3A Inhibitors Concomitant use of BELSOMRA with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir … |
| Rifampin | drug interactions | CYP3A Inducers Suvorexant exposure can be substantially decreased when co-administered with strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin). |
| Ritonavir | drug interactions | … ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) is not recommended [see … |
| Verapamil | drug interactions | … erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil). |
Source: FDA drug label (BELSOMRA), Merck Sharp & Dohme LLC, effective March 10, 2025 (SPL set e5b72731-1acb-45b7-9c13-290ad12d3951), via openFDA; the full label on DailyMed
What do FAERS reports show for suvorexant?
The FDA Adverse Event Reporting System holds 12,888 reports that list suvorexant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 696 are coded as a death and 2,028 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (2,499, against a median of 714 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as suvorexant?
11 other medicines are given the same way (oral) and in the same FDA class as suvorexant or labeled mainly for the same use (insomnia), the same class first. Insomnia lists all 14 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Daridorexant | Insomnia | none listed | $16.70 per tablet 25 mg tablet | No current entry |
| Lemborexant | Insomnia | none listed | $11.57 per tablet 10 mg tablet | No current entry |
| Zolpidem | Insomnia | 39 labelers | $0.0344 per tablet 5 mg tablet | No current entry |
| Eszopiclone | Insomnia | 26 labelers | $0.0993 per tablet 1 mg tablet | No current entry |
| Temazepam | Insomnia | 20 labelers | $0.0767 per capsule 15 mg capsule | No current entry |
| Ramelteon | Insomnia | 27 labelers | $0.660 per tablet 8 mg tablet | A presentation being discontinued |
| Zaleplon | Insomnia | 9 labelers | $0.141 per capsule 10 mg capsule | No current entry |
| Triazolam | Insomnia | 7 labelers | $0.308 per tablet 0.25 mg tablet | No current entry |
Every medicine labeled for the same conditions as suvorexant
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to suvorexant
- 11 medicines for the same use
- Other orexin receptor antagonists
- the pharmacologic class, with prices and generics
- Suvorexant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other