IMOVANE

What it is

IMOVANE contains 7.5 mg of the active ingredient zopiclone. Zopiclone is a cyclopyrrolone derivative and short-acting hypnotic agent. The tablets are white to off-white oval film-coated tablets with a breakline on one side and plain on the other side.

Approved indications

— Short term treatment of insomnia (7–14 days).

Dosing overview

For adults, the recommended dose is 7.5 mg by oral administration shortly before retiring, and this dose should not be exceeded. Depending on clinical response, the dose may be lowered to 3.75 mg. Use the lowest effective dose for short term treatment (7–14 days). In elderly and/or debilitated patients, an initial dose of 3.75 mg is recommended. The dose may be increased to a maximum of 7.5 mg if the starting dose does not offer adequate therapeutic effect, but in clinical trials, 25% of elderly patients treated with zopiclone experienced CNS side-effects at the higher dose. In patients with hepatic insufficiency, the recommended dose is 3.75 mg depending on acceptability and efficacy, with up to 7.5 mg used with caution in appropriate cases. In patients with renal insufficiency, treatment should start with 3.75 mg. IMOVANE should be taken in a single intake and not be readministered during the same night.

Key safety warnings

IMOVANE should be prescribed for short periods only (7–14 days), and continuous long term use is not recommended. Use may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence or abuse increases with dose and duration of treatment, with cases of dependence reported more frequently in patients treated for longer than 4 weeks. Complex sleep behaviours, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of IMOVANE. Patients can be seriously injured or injure others during complex sleep behaviours, and such injuries may be fatal. Other complex sleep behaviours such as preparing and eating food, making phone calls, or having sex with amnesia for the event have also been reported. IMOVANE should be discontinued immediately if a patient experiences a complex sleep behaviour. Anterograde amnesia may occur, especially when sleep is interrupted or when retiring to bed is delayed after intake of the tablet. To reduce the possibility of anterograde amnesia, patients should take the tablet strictly when retiring for the night and ensure they are able to have a full night sleep. IMOVANE can impair daytime function in some patients even when taken as instructed. Some patients may still have zopiclone blood levels in the morning on the day following use that are high enough to produce impairment. Patients should be warned that impairment can occur despite feeling fully awake, in the absence of symptoms, or even with subjective improvement. Concomitant use of opioids with IMOVANE may result in sedation, respiratory depression, coma and death. Reserve concomitant prescribing of opioids and IMOVANE for use in patients for whom alternative treatment options are inadequate. If prescribed together, use the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. IMOVANE does not constitute a treatment of depression and may even mask its symptoms. It should be administered with caution in patients exhibiting symptoms of depression, including those with latent depression, as suicidal tendencies may be present. The lowest possible quantity of IMOVANE should be supplied to these patients to reduce the risk of intentional overdosage.

Contraindications

IMOVANE is contraindicated in patients with known hypersensitivity to zopiclone or any of the excipients, prior or concomitant use of alcohol, myasthenia gravis, severe impairments of respiratory function, acute cerebrovascular accident, sleep apnoea syndrome, severe hepatic insufficiency, and patients who have previously experienced complex sleep behaviours after taking zopiclone. IMOVANE is contraindicated in children.

PBS listing

IMOVANE 7.5 mg tablets are listed on the PBS as 2 items with restricted access at an ex-manufacturer price of A$14.96.

Regulatory history

IMOVANE (zopiclone 7.5 mg tablets) was first listed on the ARTG on 9 November 2009.