Eszopiclone

Eszopiclone is a non-benzodiazepine hypnotic, chemically a close relative of zopiclone, that acts on the brain’s GABA-A receptors to shorten the time it takes to fall asleep and to cut down on night-time waking. According to the UK Summary of Product Characteristics (SmPC), it is indicated for insomnia in adults, usually for a short period, and medicines of this type are reserved for sleeplessness that is severe, disabling or causing marked distress. Before a hypnotic is started, the underlying reason for the insomnia should be looked for and treated where possible; if sleep has not improved after seven to fourteen days, the SmPC advises that the patient be reassessed for a physical or psychiatric cause.

This listing covers eszopiclone tablets in three strengths: 1 mg, 2 mg and 3 mg. Each strength comes in packs of 50, 100 or 150 tablets. These are imported generic tablets that are not covered by a UK licence.

The usual adult starting dose is 1 mg, swallowed whole just before bed. If clinically needed it can be raised to 2 mg or 3 mg, but the total should never exceed 3 mg, and the tablet should not be taken again during the same night. Trial data suggest that the effective dose for most adults is 2 or 3 mg. People aged 65 and over start on 1 mg and should not go above 2 mg; the same 2 mg ceiling applies in severe renal impairment and in adults taking potent CYP3A4 inhibitors. Courses are kept as short as possible, typically no longer than four weeks including tapering, and only in selected cases of chronic insomnia up to six months. A plan for stopping should be agreed before the first dose. Allow at least eight hours for uninterrupted sleep, and avoid driving or using machinery for twelve hours after a dose.

In the UK, eszopiclone is a prescription-only medicine (POM). It is licensed as Lunivia 1 mg, 2 mg and 3 mg film-coated tablets, with axunio Pharma GmbH as the licence holder, and the SmPC and patient leaflet for Lunivia are published on the electronic medicines compendium. Imported generics are not covered by that UK licence.

Eszopiclone must not be used by anyone allergic to it or to zopiclone, or by people with myasthenia gravis, severe breathing problems, severe sleep apnoea or severe liver failure. It is not for use in anyone under 18, and is also ruled out for those who have had complex sleep behaviours after a hypnotic, and for over-65s taking a strong CYP3A4 inhibitor. Combining it with opioids can cause deep sedation, slowed breathing, coma or death, so such combinations are kept to a minimum. Alcohol should be avoided, and other sedatives such as antipsychotics, antiepileptics or sedating antihistamines add to drowsiness. Azole antifungals, macrolide antibiotics and grapefruit juice raise blood levels, whereas rifampicin, carbamazepine, phenytoin and St John’s Wort lower them.

The most frequent complaint is an unpleasant taste in the mouth. Headache, daytime sleepiness, dizziness, unusual dreams, memory lapses, nervousness and blurred vision in older people are also common. Sleepwalking, “sleep driving” or other activities carried out without being fully awake have been reported and should prompt a rethink of treatment. Dependence and withdrawal can develop even at recommended doses, and a brief spell of rebound insomnia may follow stopping. Tapering slowly reduces these effects. Whether eszopiclone suits you, at what strength and for how long is a decision for your prescriber.