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SUVOREXANT
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Evaluation of QTc Interval
- The effects of suvorexant on the QTc interval were evaluated in a randomized, placebo-, and active-controlled (moxifloxacin 400 mg) crossover study in healthy subjects (n=53). The upper bound of the one-sided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTc interval was below 10 ms based on analysis of suvorexant doses up to 240 mg, 12 times the maximum recommended dose. BELSOMRA thus does not prolong the QTc interval to any clinically relevant extent.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
15057
38366530
Odds Ratio = 0.106
Drug Property Information
ATC Code(s):
- N05CM19 - suvorexant
- N05CM - Other hypnotics and sedatives
- N05C - HYPNOTICS AND SEDATIVES
- N05 - PSYCHOLEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:suvorexant
Active Ingredient UNII:081L192FO9
Drugbank ID:DB09034
PubChem Compound:24965990
CTD ID: C551624
CAS Number:1030377-33-3
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
[H][C@@]1(C)CCN(CCN1C(=O)C1=C(C=CC(C)=C1)N1N=CC=N1)C1=NC2=C(O1)C=CC(Cl)=C2
[H][C@@]1(C)CCN(CCN1C(=O)C1=C(C=CC(C)=C1)N1N=CC=N1)C1=NC2=C(O1)C=CC(Cl)=C2
Reference
N/A
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