Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lemborexant
Drug ID BADD_D02563
Description Lemborexant is a novel dual orexin receptor antagonist used in the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.[L10863] Recent research in the field of sleep disorders has revealed that insomnia is likely driven not by the inability of the brain to "switch on" sleep-related circuits, but rather an inability to "switch-off" wake-promoting circuits.[A189006,A189030] Whereas historically popular pharmacologic treatments for insomnia (e.g. [zopiclone], [zolpidem], benzodiazepines) focus on enhancing sleep drive via modulation of GABA and melatonin receptors, lemborexant and other orexin antagonists (e.g. [suvorexant]) act to counteract inappropriate wakefulness.[A189006] This novel mechanism of action offers potential advantages over classic hypnotic agents, including a more favorable adverse effect profile and potentially greater efficacy, and may signal the beginning of a new wave of treatment options for patients suffering from insomnia.[A189006]
Indications and Usage Lemborexant is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.[L10863]
Marketing Status approved; investigational
ATC Code N05CM21
DrugBank ID DB11951
KEGG ID D11022
MeSH ID C000634104
PubChem ID 56944144
TTD Drug ID D0A7ZK
NDC Product Code 62856-410; 62856-455; 62856-405; 60510-405; 60510-410
UNII 0K5743G68X
Synonyms lemborexant | dayvigo | (1R,2S)-2-(((2,4-dimethyl-5-pyrimidinyl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoro-2-pyridinyl)cyclopropanecarboxamide | cyclopropanecarboxamide, 2-(((2,4-dimethyl-5-pyrimidinyl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoro-2-pyridinyl)-, (1R,2S)-
Chemical Information
Molecular Formula C22H20F2N4O2
CAS Registry Number 1369764-02-2
SMILES CC1=NC(=NC=C1OCC2(CC2C(=O)NC3=NC=C(C=C3)F)C4=CC(=CC=C4)F)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.0020.000666%
Abnormal dreams19.02.03.001; 17.15.02.0010.003619%Not Available
Altered state of consciousness19.07.01.003; 17.02.04.0010.000261%Not Available
Anxiety19.06.02.0020.001777%
Aphasia19.21.01.001; 17.02.03.0010.000287%
Aspiration22.02.07.0070.000131%
Cataplexy17.15.01.003; 15.05.04.010; 19.02.02.0030.000666%Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.000444%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.000862%
Drug ineffective08.06.01.0060.005619%Not Available
Dyskinesia17.01.02.0060.000444%
Enuresis20.02.02.003; 19.07.04.0010.000444%Not Available
Feeling abnormal08.01.09.0140.000862%Not Available
Hallucination19.10.04.0030.001777%
Hallucination, auditory19.10.04.0040.000287%Not Available
Hallucination, visual19.10.04.0070.000287%Not Available
Hangover08.01.09.0180.000666%Not Available
Headache17.14.01.0010.003397%
Hepatic function abnormal09.01.02.0010.000196%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.0280.000444%
Loss of consciousness17.02.04.0040.000287%Not Available
Memory impairment19.20.01.003; 17.03.02.0030.000287%
Migraine24.03.05.003; 17.14.02.0010.000287%Not Available
Muscle twitching15.05.03.0050.000444%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000444%
Nightmare19.02.03.0030.006638%Not Available
Panic attack19.06.04.0010.000444%Not Available
Restlessness19.11.02.002; 17.02.05.0210.000287%
Seizure17.12.03.0010.000457%
Sleep paralysis19.02.02.004; 17.15.02.0050.009525%Not Available
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