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SOLRIAMFETOL
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- The effect of solriamfetol 300 mg and 900 mg (twice and six times the maximum recommended dose, respectively) on the QTc interval was evaluated in a randomized, double-blind, placebo-, and positive-controlled (moxifloxacin 400 mg), 4-period, crossover study in 60 healthy subjects. A large increase in heart rate was observed in both solriamfetol treatment groups (mean change from baseline in HR of 21 and 27 bpm in the 300 and 900 mg groups, respectively, compared with 8 bpm in the placebo group). These heart rate effects impact the interpretability of the QTc effects, particularly in the 900 mg group. In this study, solriamfetol 300 mg did not prolong the QTcF interval to a clinically relevant extent.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587
Odds Ratio = N/A
Drug Property Information
ATC Code(s):
- N06BA14 - solriamfetol
- N06BA1 -
- N06BA - Centrally acting sympathomimetics
- N06B - "PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS"
- N06 - PSYCHOANALEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:SOLRIAMFETOL
Active Ingredient UNII:939U7C91AI
Drugbank ID:DB14754
PubChem Compound:N/ADIR Classification
CTD ID:C000623308
CAS Number:178429-62-4
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
N[C@@H](COC(N)=O)CC1=CC=CC=C1
N[C@@H](COC(N)=O)CC1=CC=CC=C1
Reference
N/A
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