Suvorexant
Suvorexant is an orexin receptor antagonist (a sleep medicine that quiets the brain's wake signals) used to treat insomnia, including trouble falling asleep and trouble staying asleep.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Suvorexant (Belsomra) treats insomnia (trouble falling asleep, staying asleep or both) by blocking orexin, the brain's own wake signal. It has been on the market for over a decade and is usually considered after sleep-habit changes and older sleep medicines. Most people tolerate it well, and the side effect they notice most is next-day drowsiness, sometimes with headache or strange dreams. Stop it and call your prescriber if you sleep-walk, sleep-drive or do things while not fully awake, or if your mood darkens or suicidal thoughts appear. Take it only with a full night of sleep ahead, skip alcohol, and think twice about driving the next morning.
Clinical pearls
- Take it within 30 minutes of bedtime and not right after a meal, which can slow how quickly it works.
- Grapefruit juice and drugs like clarithromycin, fluconazole and diltiazem raise its levels, so mention Belsomra whenever something new is prescribed.
- Mention sleep apnea, COPD or narcolepsy first; it is not for narcolepsy, and severe breathing problems were not studied.
- As a Schedule IV controlled substance, it has legal refill limits, so plan ahead before you run out.
Patient information guide A plain-language walkthrough of Suvorexant, written from its FDA label.
What Suvorexant is used for
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Suvorexant is used for one condition:
- Insomnia, including trouble falling asleep and/or trouble staying asleep (Belsomra tablets).
How Suvorexant works
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Suvorexant is an orexin receptor antagonist. Orexins are brain chemicals that promote wakefulness. Suvorexant blocks them from attaching to their receptors, OX1R and OX2R. This is thought to reduce the brain's wake drive and help you fall and stay asleep.
Suvorexant dosage
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Belsomra is a tablet taken by mouth, no more than once per night. Your prescriber will use the lowest dose that works for you.
- Take it within 30 minutes of going to bed.
- Make sure at least 7 hours remain before you need to wake up.
- It may work more slowly if taken with or right after a meal.
- Dose changes may be needed if you take certain other medicines. Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Suvorexant prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- General dosing (insomnia patients)
- 10 mg, no more than once per night, taken within 30 minutes of going to bed, with at least 7 hours remaining prior to planned awakening
- If the 10 mg dose is well-tolerated but not effective, the dose can be increased
- Maximum: 20 mg taken no more than once per night
- Time to effect may be delayed if taken with or soon after a meal
- Patients receiving moderate CYP3A inhibitors
- 5 mg taken no more than once per night
- Maximum: The dose generally should not exceed 10 mg
- Not recommended for use with strong CYP3A inhibitors
- Obese patients and women (special populations)
- Exposure is increased in obese compared to non-obese patients, and in women compared to men
- Particularly in obese women, consider the increased risk of exposure-related adverse effects before increasing the dose
- Use with other CNS depressant drugs
- Dosage reduction of BELSOMRA and/or the other drug(s) may be necessary because of potentially additive effects
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient ( 2.1 ). Recommended dose is 10 mg, no more than once per night taken within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg once daily ( 2.1 , 2.2 ). Time to effect may be delayed if taken with or soon after a meal ( 2.1 ). 2.1 Dosing Information Use the lowest dose effective for the patient. For all BELSOMRA doses, take no more than once per night within 30 minutes of going to bed (with at least 7 hours remaining prior to planned awakening). Time to effect of BELSOMRA may be delayed if taken with or soon after a meal [see Clinical Pharmacology (12.3) ]. The recommended dose for BELSOMRA is 10 mg, taken no more than once per night. If the 10 mg dose is well-tolerated but not effective, the dose can be increased. The maximum recommended dose of BELSOMRA is 20 mg taken no more than once per night. 2.2 Special Populations Exposure to BELSOMRA is increased in obese compared to non-obese patients, and in women compared to men. Particularly in obese women, the increased risk of exposure-related adverse effects should be considered before increasing the dose [see Clinical Pharmacology (12.3) ] . 2.3 Use with CNS Depressants When BELSOMRA is combined with other CNS depressant drugs, dosage reduction of BELSOMRA and/or the other drug(s) may be necessary because of potentially additive effects [see Warnings and Precautions (5.1) ] . 2.4 Dosage Adjustments with CYP3A Inhibitors When used with moderate CYP3A inhibitors, the recommended dosage of BELSOMRA is 5 mg taken no more than once per night (the dose generally should not exceed 10 mg). BELSOMRA is not recommended for use with strong CYP3A inhibitors [see Drug Interactions (7.2) ] .
Read the full Dosage and Administration section on DailyMed →
Suvorexant side effects
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The most common side effect is sleepiness. Others seen in studies include:
Common side effects
- Sleepiness or drowsiness (somnolence)
- Headache
- Dizziness
- Abnormal dreams
- Dry mouth
- Diarrhea
- Cough
- Upper respiratory tract infection (cold-like symptoms)
When to get medical help
- Stop the medicine and call your doctor right away if you sleep-walk, sleep-drive, or do other activities (like eating or making phone calls) while not fully awake.
- Call your doctor right away if you notice worsening depression, suicidal thoughts, or any new behavior changes.
- Tell your doctor if you can't move or speak for a few minutes when falling asleep or waking up.
- Tell your doctor about vivid, disturbing hallucinations around sleep.
- Tell your doctor about episodes of leg weakness lasting seconds to minutes, at night or during the day.
- Call your doctor if you feel sleepy during the day or drive drowsy.
- Talk to your doctor if your insomnia hasn't improved after 7 to 10 days or gets worse.
Sleepiness and some other effects increase with higher doses. Get help right away for sleep-walking, sleep-driving, worsening depression, or suicidal thoughts.
Suvorexant warnings and precautions
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- Next-day impairment: Belsomra can affect alertness and driving, even with proper use. Effects can last up to several days after stopping in some people. Higher doses carry more risk.
- Complex sleep behaviors: Sleep-walking, sleep-driving and other activities without full awareness can occur, often without memory of them. Stop the medicine immediately if this happens.
- Depression and suicidal thoughts: These may worsen, and the risk rises with dose.
- Sleep paralysis, hallucinations, and cataplexy-like symptoms: These can occur, and the risk rises with dose.
- Breathing problems: Use caution with compromised breathing. It has not been studied in severe sleep apnea or severe COPD.
- Persistent insomnia: If it doesn't improve after 7 to 10 days, another condition may be involved.
Suvorexant interactions
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Several substances can change how Belsomra works or how sedating it is.
- Alcohol: adds to impairment, so avoid it.
- Other sedating drugs (benzodiazepines, opioids, tricyclic antidepressants): increase sedation.
- Other sleep medicines: combining is not recommended.
- Strong CYP3A inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir): raise suvorexant levels, so not recommended.
- Moderate CYP3A inhibitors (diltiazem, verapamil, erythromycin, fluconazole, grapefruit juice): raise levels, so a lower dose is used.
- Strong CYP3A inducers (rifampin, carbamazepine, phenytoin): may make it less effective.
- Digoxin: levels may rise slightly and should be monitored.
Interactions listed in the FDA-approved label
From the Suvorexant prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Alcohol: Additive psychomotor impairment was demonstrated; there was no alteration in the pharmacokinetics of BELSOMRA.
- Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan): Metabolism by CYP3A is the major elimination pathway for suvorexant, so these inhibitors affect its exposure. Concomitant use is not recommended.
- Moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil): Metabolism by CYP3A is the major elimination pathway for suvorexant, so these inhibitors affect its exposure. Recommended dose is 5 mg; may be increased to 10 mg once per night if the 5 mg dose is not effective; dose generally should not exceed 10 mg.
- Strong CYP3A inducers (e.g., rifampin, carbamazepine, phenytoin): Suvorexant exposure can be substantially decreased and the efficacy of BELSOMRA may be reduced.
- Digoxin: Concomitant administration slightly increased digoxin levels due to inhibition of intestinal P-gp. Monitor digoxin concentrations when co-administering.
- Other CNS depressant drugs: Potentially additive effects. Dosage reduction of BELSOMRA and/or the other drug(s) may be necessary.
Read the label’s full interactions text
7 DRUG INTERACTIONS CYP3A inhibitors: Recommended dose is 5 mg when used with moderate CYP3A inhibitors. Dose can be increased to 10 mg once per night if the 5 mg dose is not effective. Not recommended for use in patients taking strong CYP3A inhibitors ( 2.4 , 7.2 ). Strong CYP3A inducers: Efficacy may be reduced ( 7.2 ). Digoxin: Monitor digoxin concentrations ( 7.3 ). 7.1 CNS-Active Agents When BELSOMRA was co-administered with alcohol, additive psychomotor impairment was demonstrated. There was no alteration in the pharmacokinetics of BELSOMRA [see Warnings and Precautions (5.1 , 5.3) and Clinical Pharmacology (12.3) ]. 7.2 Effects of Other Drugs on BELSOMRA Metabolism by CYP3A is the major elimination pathway for suvorexant. 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) ]. 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). The dose generally should not exceed 10 mg in patients receiving moderate CYP3A inhibitors [see Clinical Pharmacology (12.3) ]. CYP3A Inducers Suvorexant exposure can be substantially decreased when co-administered with strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin). The efficacy of BELSOMRA may be reduced [see Clinical Pharmacology (12.3) ]. 7.3 Effects of BELSOMRA on Other Drugs Digoxin Concomitant administration of BELSOMRA with digoxin slightly increased digoxin levels due to inhibition of intestinal P-gp. Digoxin concentrations should be monitored when co-administering BELSOMRA with digoxin [see Clinical Pharmacology (12.3) ].
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Suvorexant
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- Do not use if you have narcolepsy.
- Tell your prescriber about depression or suicidal thoughts.
- Mention any breathing conditions like sleep apnea or COPD.
- Not recommended with severe liver impairment. No dose change is needed for mild or moderate liver problems or for kidney problems.
- Women and people with obesity have higher drug levels, so dose increases are considered carefully.
- Older adults are at higher risk of falls.
- Not established for children.
- Pregnancy: human data are insufficient to establish a risk.
- Breastfeeding: small amounts pass into breast milk, with a relative infant dose under 1%.
Suvorexant overdose
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In studies, very high doses caused more and longer sleepiness. If too much is taken, get medical help or contact a poison control center right away. Treatment is supportive, with monitoring of vital signs. Dialysis is not expected to help.
What Suvorexant does in the body
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Suvorexant binds tightly to both orexin receptors, OX1R and OX2R, and blocks wake-promoting signals. Blocking this system may also explain narcolepsy-like side effects such as cataplexy-like weakness. In a heart-rhythm study at doses up to 12 times the maximum recommended dose, it did not prolong the QTc interval to any clinically relevant extent.
How your body processes Suvorexant
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On an empty stomach, suvorexant typically peaks in about 2 hours. A high-fat meal delays the peak by about 1.5 hours. The body clears it mainly through the liver (mostly by the CYP3A enzyme), and most leaves in the stool. Its half-life is about 12 hours, and steady levels are reached in about 3 days.
How to store Suvorexant
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), . Store in the original package until use to protect from light and moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Suvorexant
195 supplements and herbal products have documented interactions with Suvorexant in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 9
- Moderate · 147
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Suvorexant: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Suvorexant — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How and when should I take it?
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Can I drive the next day?
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Can I have a drink with it?
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What side effects should I expect, and which ones should I call about?
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What if it isn't helping?
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Is Suvorexant available over the counter?
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Is Suvorexant a controlled substance?
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When was Suvorexant first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Suvorexant on HelloPharmacist
Suvorexant forms and strengths (how it comes)
Suvorexant is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Belsomra is used to treat insomnia with trouble falling asleep and/or staying asleep.
- Belsomra is taken by mouth no more than once per night.
- Belsomra should be taken within 30 minutes of going to bed, with at least 7 hours left before waking.
- Belsomra may take longer to work if taken with or soon after a meal.
Suvorexant on the U.S. market: products, makers and brands
How Suvorexant appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 4 Suvorexant product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2012. Brand names on the directory include Belsomra; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Suvorexant is used (Medicaid data)
A general measure of how commonly Suvorexant is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Suvorexant is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Suvorexant prescribed? Of the 1,601 medications we measure, Suvorexant ranks #636 by Medicaid prescriptions — more than 60% of them.
Utilization by Suvorexant product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
suvorexant 20 MG Oral Tablet Most dispensed
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547116
suvorexant 10 MG Oral Tablet
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547104
suvorexant 15 MG Oral Tablet
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547112
suvorexant 5 MG Oral Tablet
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1547573
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Suvorexant, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 20 listed Suvorexant NDCs with Medicaid activity.
Compare Suvorexant products
A representative set of FDA-listed product records for Suvorexant — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 5 mg | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 10 mg | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 15 mg | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 20 mg | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Suvorexant NDCs →
Suvorexant side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Suvorexant — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Suvorexant in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Suvorexant FDA approval history
How Suvorexant went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Suvorexant recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Suvorexant recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellp… Lots: Lots 2090019 and 2123744, Exp. 4/30/2027 FDA record D-0584-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1547099 1 dose form · 4 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1547103In current FDA listings
Look up RxCUI 1547099 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Suvorexant supply and shortage status
Whether Suvorexant is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Suvorexant costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 5 mg | $15.20 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 10 mg | $15.21 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 15 mg | $15.19 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 20 mg | $15.21 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Suvorexant brand names
Suvorexant is sold under one brand name in the FDA directory — Belsomra. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Suvorexant: manufacturers and labelers
One company lists Suvorexant products with the FDA. By number of product records, the largest are Merck Sharp & Dohme LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Suvorexant drug class (RxNorm)
Suvorexant belongs to the Orexin Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Suvorexant page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →