Suvorexant
Generic Name: Suvorexant
Brand Names: Belsomra
Suvorexant is the first approved orexin receptor antagonist for insomnia treatment.
Drug Class
Orexin Receptor Antagonist (Dual Orexin Receptor Antagonist — DORA)
DEA Schedule
Schedule Schedule IV
Pregnancy
Not formally categorized; limited human data — use during pregnancy only if clearly needed
Available Forms
5 mg oral tablet, 10 mg oral tablet, 15 mg oral tablet, 20 mg oral tablet
What It's Used For
Dosage Quick Reference
These are general dosage guidelines. Your doctor will determine the appropriate dose for your specific situation.
| Condition | Starting Dose | Typical Maintenance Dose |
|---|---|---|
| Insomnia — difficulty with sleep onset | 10 mg once nightly, within 30 minutes of bedtime | 10–20 mg once nightly (max 20 mg) |
| Insomnia — difficulty with sleep maintenance | 10 mg once nightly, within 30 minutes of bedtime | 10–20 mg once nightly (max 20 mg) |
| Insomnia with moderate CYP3A4 inhibitor use | 5 mg once nightly | 5 mg once nightly (do not exceed) |
Side Effects
Common Side Effects:
- Somnolence (next-day drowsiness)
- Headache
- Dizziness
- Abnormal dreams
- Dry mouth
- Cough
- Upper respiratory tract infection
Serious Side Effects:
- Complex sleep behaviors (sleepwalking, sleep-driving)
- Sleep paralysis
- Hypnagogic/hypnopompic hallucinations
- Suicidal ideation
- Cataplexy-like symptoms
Drug Interactions
Major Drug & Food Interactions
- Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir): Contraindicated — dramatically increases suvorexant levels and risk of excessive sedation and CNS depression.
- Moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem, verapamil, grapefruit juice): Reduce suvorexant dose to 5 mg nightly; monitor for excessive sedation.
- CNS depressants (benzodiazepines, opioids, other sedative-hypnotics, alcohol): Additive CNS depression; increased risk of next-day impairment, excessive sleepiness, respiratory depression, and complex sleep behaviors.
- Strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin): May substantially reduce suvorexant effectiveness; monitor therapeutic response.
- Digoxin: Suvorexant may increase digoxin levels; monitor digoxin serum concentrations when co-administered.
Additional Information
Suvorexant is a dual orexin receptor antagonist (DORA) used to treat insomnia characterized by difficulty with sleep onset and/or sleep maintenance. It represents a novel mechanism for treating insomnia by blocking wake-promoting orexin signaling.
Mechanism of Action
Suvorexant works by antagonizing orexin receptors:
- Dual orexin receptor antagonism: Blocks both OX1R and OX2R receptors
- Suppresses wake drive: Orexins A and B promote and maintain wakefulness
- Promotes natural sleep: Reduces orexin-driven arousal without sedation
- Preserves sleep architecture: May maintain more normal sleep stages than GABA-targeting drugs
Orexin neurons are most active during wakefulness and silent during sleep.
Available Formulations
Suvorexant is available as tablets:
- 5 mg, 10 mg, 15 mg, 20 mg tablets
Medical Uses
FDA-Approved Indication:
- Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance
Suvorexant improves both time to fall asleep and total sleep time.
Dosing Guidelines
Adults:
- Starting dose: 10 mg once nightly within 30 minutes of bedtime
- May increase to 20 mg if 10 mg is tolerated but not effective
- Maximum: 20 mg nightly
Time Requirements:
- Take within 30 minutes of going to bed
- Allow at least 7 hours before planned awakening
With CYP3A4 Inhibitors:
- Moderate CYP3A4 inhibitors: Start at 5 mg; max 10 mg
- Strong CYP3A4 inhibitors: Avoid use
Important Safety Information
Controlled Substance:
- Schedule IV controlled substance
Contraindications:
- Narcolepsy
Warnings and Precautions:
- CNS depressant effects: Impaired alertness and motor coordination, including next-day impairment
- Sleep paralysis, hypnagogic/hypnopompic hallucinations: May occur
- Complex sleep behaviors: Sleepwalking, sleep-driving, and other activities while not fully awake (discontinue if occurs)
- Worsening of depression/suicidal ideation: Monitor patients with depression
- Compromised respiratory function: Use with caution in patients with respiratory impairment
- Cataplexy-like symptoms: Possible in susceptible individuals
Drug Interactions
Strong CYP3A4 Inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir):
- Avoid concomitant use
Moderate CYP3A4 Inhibitors (diltiazem, erythromycin, fluconazole):
- Start at 5 mg; max 10 mg
Strong CYP3A4 Inducers (rifampin, carbamazepine, phenytoin):
- May reduce efficacy substantially
Other CNS Depressants (alcohol, opioids, benzodiazepines):
- Additive CNS depression; use with caution
Digoxin:
- Suvorexant may increase digoxin levels; monitor
Special Populations
- Hepatic Impairment:
- Mild to moderate: No adjustment
- Severe: Not recommended
- Renal Impairment: No adjustment needed
- Elderly: No specific adjustment; consider 5 mg starting dose
- Pregnancy: Limited data; not recommended
- Lactation: Unknown if excreted in milk
- Pediatric: Safety not established
Frequently Asked Questions
Related Health Conditions
This medication is commonly used to treat or manage the following conditions:
Medical Disclaimer: This information is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting, stopping, or changing any medication. Your doctor can provide personalized recommendations based on your specific health condition and medical history.
Related Medications
Other medications in the same category
Questions About This Medication?
Talk to your doctor or pharmacist about whether Suvorexant is right for you.
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