VOQUILY

What it is

VOQUILY contains melatonin in capsule form (2 mg, 3 mg or 5 mg) or oral solution form (1 mg/mL) . Melatonin is a hormone and antioxidant that is involved in the synchronisation of circadian rhythms to the diurnal light-dark cycle . Melatonin has a hypnotic/sedative effect and increases propensity for sleep .

Approved indications

— Short-term treatment of jet lag in adults aged 18 and over . — Sleep disorders in children and adolescents aged 6 to 18 with neurodevelopmental disorders including autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been insufficient .

Dosing overview

For jet lag in adults, the recommended dose is 2 mg once daily taken at the preferred local sleep time . The dose may be increased to up to a maximum of 5 mg if the standard dose does not adequately alleviate symptoms . VOQUILY should be taken for the shortest period of time, with a maximum duration of 5 days . For neurodevelopmental disorders in children and adolescents, the recommended starting dose is 2 mg once daily taken 30 minutes to 1 hour before bedtime . If an inadequate response has been observed, the daily dose should be increased to a maximum of 5 mg per day . It is recommended that VOQUILY is administered on an empty stomach and food is not consumed 1 hour before and 1 hour after intake of VOQUILY .

Key safety warnings

Melatonin may cause daytime drowsiness, and VOQUILY should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety . VOQUILY is not recommended prior to driving and using machines until the effects are known . There is no data concerning the use of melatonin in patients with autoimmune diseases, and VOQUILY is not recommended in patients with autoimmune diseases . Melatonin may increase seizure frequency in patients experiencing seizures (e.g. epileptic patients) . Daytime endogenous blood melatonin concentration is markedly elevated in patients with hepatic impairment due to reduced clearance, and VOQUILY is not recommended for patients with hepatic impairment . Limited data is available for the use of melatonin in patients with renal impairment, and VOQUILY is not recommended for patients with renal impairment . Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, and the use of melatonin in combination with these drugs is not recommended . Melatonin may increase the anticoagulation activity of warfarin, and the combination of warfarin or other vitamin K antagonists with melatonin may require dose adjustment of the anticoagulant drugs and should be avoided .

Contraindications

VOQUILY is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients .

PBS listing

No information regarding PBS listing is available in the provided documents.

Regulatory history

VOQUILY melatonin capsules (2 mg, 3 mg and 5 mg) and oral solution (1 mg/mL) were first listed on the ARTG on 2023-10-27 . The AusPAR (Australian Public Assessment Report) was approved on 2023-10-03 for the treatment of jet lag in adults aged 18 and over and sleep disorders in children and adolescents aged 6 to 18 with neurodevelopmental disorders including ASD and ADHD where sleep hygiene measures have been insufficient .