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Dayvigo
Published
Product name
Dayvigo
Active ingredient
Lemborexant
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Dayvigo (lemborexant) was approved for the following therapeutic use:
Dayvigo is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest DSM criteria
How this medicine works
Lemborexant is a competitive antagonist of both orexin receptors, orexin receptors type 1 (OX1R) and orexin receptors type 2 (OX2R), with a higher affinity for OX2R. It belongs to the pharmacologic class of orexin receptor antagonists. The orexin neuropeptide signalling system is a central promoter of wakefulness. Blocking the binding of wake promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive. Antagonism or orexin receptors may also underlie potential adverse effects such as signs of narcolepsy/cataplexy. Lemborexant administered to mice at oral doses greater than 10 mg/kg resulted in behaviour characteristic of cataplexy when presented with chocolate. Chocolate is a stimulus that has been demonstrated to increase cataplexy occurrences in narcoleptic mice.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Dayvigo was considered favourable for the therapeutic use approved.
Sponsor