Lunivia® (eszopiclone)

Prescribing information is available at the bottom of the page.

Lunivia is indicated for the treatment of insomnia, in adults, usually for short-term duration. Benzodiazepines or benzodiazepine-like substances are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

The recommended starting dose is 1 mg. The dose can be increased to 2 mg or 3 mg if clinically indicated. The lowest effective dose should be used. The total dose of Lunivia should not exceed 3 mg.

Lunivia will be available in the UK from February 2025 with a NHS list price of £3.99 (30 tablets) for the 1 mg, 2 mg, and 3 mg packs.

For further information on Lunivia, please contact Leith Healthcare, axunio Pharma's UK partner.

Summary of Product Characteristics

Patient Information Leaflet

Adverse event reporting

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UK Prescribing Information. Lunivia® (eszopiclone) Before prescribing, consult the full Summary of Product Characteristics (SmPC). Presentation Eszopiclone 1 mg, 2 mg, and 3 mg film-coated tablets. Therapeutic indication Lunivia is indicated for the treatment of insomnia, in adults, usually for short-term duration. Benzodiazepines or benzodiazepine-like substances are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. Posology In all cases, the length of treatment should be for the minimum duration necessary for effective treatment and should not exceed four weeks including the period of tapering off. In certain cases, for example in patients with chronic insomnia, it may be necessary to extend the treatment period up to a maximum duration of 6 months. Eszopiclone should be taken in a single intake immediately at bedtime and not be readministered. The recommended starting dose is 1 mg. The dose can be increased to 2 mg or 3 mg if clinically indicated. The lowest effective dose should be used. The total dose should not exceed 3 mg. Elderly aged 65 or older: The recommended starting dose is 1 mg. In these patients, the dose may be increased to 2 mg if clinically indicated. Renal impairment: The maximum recommended dose in patients with severe renal impairment is 2 mg. Method of administration The tablets must not be crushed or broken prior to ingestion. Contraindications - Hypersensitivity to the active substance, to zopiclone or to any of the excipients - Myasthenia gravis - Severe respiratory insufficiency - Severe sleep apnoea syndrome - Severe hepatic insufficiency - Patients who have experienced complex sleep behaviours after taking eszopiclone, zopiclone or any other hypnotic agents - Elderly patients receiving concomitant potent CYP3A4 inhibitors - Children and adolescent under 18 years of age. Warnings and precautions for use General The cause of insomnia should be identified wherever possible. The underlying factors should be treated before a hypnotic is prescribed. Caution is advised when prescribing in the following circumstances: Chronic respiratory impairment; A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Risk from concomitant use of opioids; If a decision is made to prescribe eszopiclone concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible. Risk of dependence; Use of benzodiazepine-like substances may lead to the development of physical and psychological dependence or abuse of these products. The risk of dependence increases with: - Dose and duration of treatment - patients with a history of psychiatric disorders and/or alcohol substance or drug abuse - patients who have marked personality disorders. Withdrawal and rebound insomnia; To reduce the risk of withdrawal and/or rebound insomnia, the dose of eszopiclone should be decreased gradually. Tolerance; In clinical studies with eszopiclone, no development of tolerance to any parameter of sleep measurements was observed during treatment periods of up to six months. Interactions Concomitant use with alcohol should be avoided because the sedative effect of eszopiclone may be enhanced. A dose reduction for eszopiclone may be necessary when it is co-administered with agents with known CNS-depressant effects such as olanzapine or when it is co-administered with CYP3A4 inhibitors. A dose increase for eszopiclone may be required when it is co-administered with CYP3A4 inducers. In patients with mood disorders, co-administration of eszopiclone with fluoxetine or escitalopram did not adversely affect the pharmacodynamic effects of eszopiclone or the antidepressant medicinal product. Fertility, pregnancy and lactation Eszopiclone is not recommended during pregnancy and in women of childbearing potential not using contraception. Eszopiclone should not be used during breast feeding. Effects on ability to drive and use machines Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle following administration of eszopiclone and in particular during the 12 hours following that administration. Undesirable effects Very common (≥ 1/10): dysgeusia (unpleasant taste) Common (≥ 1/100 to < 1/10): abdominal pain, abnormal dreams, anxiety, asthenia, back pain, blurred vision (predominantly in elderly patients), depression, diarrhoea, dizziness, dry mouth, dyspepsia, headache, memory impairment, migraine, myalgia, nausea, nervousness, pain, pharyngitis, rash, somnolence, thinking abnormal, vomiting. Consult the full SmPC for further information on side effects. Marketing Authorisation Holder and Numbers axunio Pharma GmbH, Van-der-Smissen-Straße 1, 22767 Hamburg, Germany PL 47848/0042-0044 Cost Lunivia 1 mg x 30 tablets, 2 mg x 30 tablets and 3 mg x 30 tablets: £3.99 per pack. Prescription conditions POM. Job code and date of preparation LUN012501 January 2025

LUN012504 January 2025