Orexin Receptor AntagonistPrescription OnlyPregnancy Cat. Not classifiedFDA Yes

Belsomra

SUVOREXANT

1 INDICATIONS AND USAGE BELSOMRA ® (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 ).

Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians · May 2026

Brand names:BELSOMRA

Rx Only

BelsomraMedication

Quick Reference

Medicine ClassOrexin Receptor Antagonist

FDA ApprovedYes

PregnancyCategory Not classified

Check Interactions Dosage Details

Quick Facts

Active ingredient: SUVOREXANT
Medicine class: Orexin Receptor Antagonist
Brand names: BELSOMRA
Availability: Prescription only (Rx)
Pregnancy category: Not classified
Half-life: half-life was increased from approximately 15 hours (range 10 - 22 hours) in healthy subjects to app
FDA approved: Yes

Belsomra (SUVOREXANT) medication overview

What Is Belsomra?

Belsomra (SUVOREXANT) belongs to the Orexin Receptor Antagonist class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.

Key Safety Information

•Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
•Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
•Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
•Avoid or limit alcohol while taking Belsomra. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
•Take Belsomra with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
•Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.

This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.

Uses & Indications

Belsomra is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.

1 INDICATIONS AND USAGE BELSOMRA ® (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 ).

Dosage Guide

The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.

Adult Dosage

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 t

Available Forms

Available Strengths

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Side Effects

Common

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections: CNS Depressant Effects and Daytime Impairment [see Warnings and Precautions (5.1) ] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions (5.2) ] Complex Sleep Behaviors [see Warnings and Precautions (5.3) ] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms [see Warnings and Precautions (5.4) ] Patients with Compromised Respiratory Function [see Warnings and Precautions (5.5) ] The most common adverse reaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) with BELSOMRA was somnolence ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In 3-month controlled efficacy trials (Study 1 and Study 2), 1263 patients were exposed to BELSOMRA including 493 patients who received BELSOMRA 15 mg or 20 mg (see Table 1 ).
In a long-term study, additional patients (n=521) were treated with BELSOMRA at higher than recommended doses, including a total of 160 patients who received BELSOMRA for at least one year.
Table 1: Patient Exposure to BELSOMRA 15 mg or 20 mg in Study 1 and Study 2 Patients Treated BELSOMRA 15 mg BELSOMRA 20 mg For ≥ 1 Day (n) 202 291 Men (n) 69 105 Women (n) 133 186 Mean Age (years) 70 45 For ≥ 3 Months (n) 118 172 The pooled safety data described below (see Table 2 ) reflect the adverse reaction profile during the first 3 months of treatment.
Adverse Reactions Resulting in Discontinuation of Treatment The incidence of discontinuation due to adverse reactions for patients treated with 15 mg or 20 mg of BELSOMRA was 3% compared to 5% for placebo.

Serious

5 WARNINGS AND PRECAUTIONS CNS Depressant Effects and Daytime Impairment: Risk of impaired alertness and motor coordination, including impaired driving;
risk increases with dose;
caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness ( 5.1 ).
Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur.
Risk increases with dose.

Rare

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Medicine Interactions

Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.

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Warnings & Contraindications

5 WARNINGS AND PRECAUTIONS CNS Depressant Effects and Daytime Impairment: Risk of impaired alertness and motor coordination, including impaired driving; risk increases with dose; caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness ( 5.1 ). Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. R

How Belsomra Works

12.1 Mechanism of Action The mechanism of action of suvorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

Pharmacokinetics

Absorption

absorption at higher doses

Half-Life

half-life was increased from approximately 15 hours (range 10 - 22 hours) in healthy subjects to app

Metabolism

Metabolism Suvorexant is mainly eliminated by metabolism, primarily by CYP3A with a minor contribution from CYP2C19

Excretion

Excretion The primary route of elimination is through the feces, with approximately 66% of radiolabeled dose recovered in the feces compared to 23% in the urine

Pregnancy & Breastfeeding Safety

Not classified

FDA Pregnancy Category Not classified

Consult your healthcare provider.

Full Pregnancy Information

Breastfeeding

Many medications pass into breast milk in varying amounts. Before using Belsomrawhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.

Storage & Handling

16.2 Storage and Handling 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), [see USP Controlled Room Temperature]. Store in the original package until use to protect from light and moisture.

Frequently Asked Questions

Sources & References

• FDA Prescribing Information — Official labeling and package insert for Belsomra
• U.S. National Library of Medicine — MedlinePlus drug information
• American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
• PubMed / MEDLINE — View clinical studies

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Medical Disclaimer

The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.