Suvorexant
BELSOMRA
What it isDual OX1 and OX2 orexin-receptor antagonist; insomnia.
Why this oneAs the first dual orexin antagonist, it established a non-GABAergic option for both sleep onset and maintenance.
What limits itNext-day somnolence requires adequate sleep time; CYP3A4 interactions, falls, and Schedule IV misuse risk remain.
FDA-approved for
- insomnia (2014)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Insomnia (sleep onset and/or maintenance) | Adults | 10 mg QHS | 10 mg QHS | 20 mg QHS |
| Insomnia, with moderate CYP3A inhibitor | Adults | 5 mg QHS | 5 mg QHS | 10 mg QHS |
Renal No adjustment needed
Hepatic Mild-moderate: no adjustment; severe: not recommended
No more than once per night; obese women have higher exposure — consider before dose increase
Instructions
- Take once per night within 30 min of bedtime, ≥7 h before planned awakening
- Onset may be delayed if taken with/soon after a meal
- With CNS depressants, dose reduction of one or both may be needed
- Not recommended with strong CYP3A inhibitors
Contraindications
- Narcolepsy
Cautions
- CNS depressant effects / next-day daytime impairment incl. driving (risk ↑ with dose)
- Worsening depression / suicidal ideation
- Complex sleep behaviors (sleep-walking/driving) — discontinue if they occur
- Sleep paralysis, hypnagogic/hypnopompic hallucinations, cataplexy-like symptoms
- Compromised respiratory function; reevaluate if insomnia persists after 7-10 days
Adverse reactions
- Somnolence
Pregnancy Insufficient human data; animal studies showed decreased maternal/fetal weight
Lactation Present in breast milk at low concentrations (relative infant dose <1%)
NO BOXED WARNINGS
Principal riskNext-day somnolence; allow seven hours before waking
Cost, est. cash$300–$2,500/month
Generic entry2029 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityNext-day somnolence, abnormal sleep behaviors and additive CNS depression.
Mechanism of action: Suvorexant ballicule
Open Suvorexant in the interactive console ↗
Memory aids: mascots and interaction avatars
Blocks orexin, allowing sleep
