DAYVIGO

What it is

Dayvigo is a film coated tablet containing lemborexant, available in 5 mg and 10 mg strengths. Lemborexant is a competitive antagonist of both orexin receptors, OX1R and OX2R, with a higher affinity for OX2R, and belongs to the pharmacologic class of orexin receptor antagonists. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria.

Dosing overview

The recommended dose of Dayvigo is 5 mg, taken no more than once per night and within a few minutes before going to bed, with at least 7 hours remaining before the planned time of awakening. If the 5 mg dose is well tolerated but greater effect is needed, the dose can be increased to 10 mg once daily, the maximum recommended dose. Dayvigo should be used at the lowest dose and for the shortest duration as clinically indicated. Time to sleep onset may be delayed if taken with or soon after a meal. The maximum recommended dose of Dayvigo is 5 mg when co-administered with weak CYP3A inhibitors. The maximum recommended dose of Dayvigo is 5 mg in patients with moderate hepatic impairment. No dose adjustment is required in elderly patients.

Key safety warnings

Dayvigo, like other sleep-promoting drugs, may impair daytime wakefulness even when used as prescribed, and prescribers should advise patients about the potential for next-day somnolence. Co-administration with other central nervous system depressants (for example, benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of central nervous system depression, which can cause daytime impairment, and dosage adjustments of Dayvigo and of concomitant central nervous system depressants may be necessary when administered together because of potentially additive effects. Patients should be advised not to consume alcohol in combination with Dayvigo. Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur with the use of Dayvigo, and prescribers should explain the nature of these events to patients when prescribing Dayvigo. Symptoms similar to mild cataplexy can occur with Dayvigo, such as periods of leg weakness lasting from seconds to a few minutes, which can occur either at night or during the day, and may not be associated with an identified triggering event. Complex sleep behaviours, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, have been reported to occur with the use of hypnotics such as Dayvigo in both hypnotic-naïve and hypnotic-experienced persons, and patients usually do not remember these events; complex sleep behaviours may occur following the first or any subsequent use of Dayvigo, with or without the concomitant use of alcohol and other central nervous system depressants, and Dayvigo should be discontinued immediately if a patient experiences a complex sleep behaviour. In clinical studies of Dayvigo in patients with insomnia, the incidence of suicidal ideation or any suicidal behaviour was higher in patients receiving Dayvigo than in those receiving placebo, and in primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions have been reported; suicidal tendencies may be present in such patients and protective measures may be required.

Contraindications

Dayvigo, like other orexin receptor antagonists, is contraindicated in patients with narcolepsy. Dayvigo is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

PBS listing

No information about PBS listing is provided in the source documents.

Regulatory history

Dayvigo was first approved on 16 July 2021, with both the 5 mg and 10 mg film coated tablet strengths listed on the ARTG on that date.