Lunivia

Instructions for use: Lunivia

Brief reference information compiled from official German sources (Gelbe Liste, Fachinfo, Apotheken Umschau). It does not replace a doctor’s consultation or the package insert. This is a prescription medicine — use it only as directed by a doctor.

Active substance

Eszopiclone (Eszopiclon) — the active S-enantiomer of zopiclone, a non-benzodiazepine hypnotic (Z-drug) of the cyclopyrrolone group, ATC N05CF04

Available forms

Film-coated tablets (Filmtabletten): 1 mg (light blue, engraved «1»), 2 mg (white, «2») and 3 mg (blue, «3»). Packs of 10, 20 or 30 tablets. The tablets must not be broken or crushed before use — the active substance has a bitter taste (this applies to all strengths). Manufacturer: HENNIG ARZNEIMITTEL GmbH & Co. KG (Germany), on the German market since 01.04.2021

Indications

Per the Fachinformation: treatment of sleep disturbances (insomnia) in adults, generally as short-term therapy. Benzodiazepines and benzodiazepine-like medicines are indicated only for severe insomnia that significantly impairs the patient’s condition

How to take

The dose is selected by the doctor. The recommended starting dose is 1 mg; if clinically necessary, the doctor may increase it to 2 or 3 mg (the usual effective dose in adults is 2–3 mg). The maximum dose is 3 mg. Take it once orally immediately before going to bed; a repeat dose during the same night is not allowed. After taking it, ensure at least 8 hours of uninterrupted sleep. The course should be as short as possible, no more than 4 weeks including gradual withdrawal; in special cases the doctor may extend it to 6 months with regular monitoring. For the elderly (65+) — a starting dose of 1 mg, maximum 2 mg. In mild and moderate hepatic impairment no adjustment is needed; in severe impairment the medicine is contraindicated. In severe renal impairment — no more than 2 mg

Contraindications

• Hypersensitivity to eszopiclone, zopiclone or the excipients
• Myasthenia gravis (myasthenia gravis)
• Severe respiratory failure
• Severe sleep apnoea syndrome
• Severe hepatic failure (risk of encephalopathy)
• Elderly patients taking potent CYP3A4 inhibitors (e.g. ketoconazole)
• Children and adolescents under 18 years of age

Possible side effects

• Very common: dysgeusia — an unpleasant bitter taste in the mouth (the hallmark side effect of eszopiclone)
• Common: headache
• Common: daytime drowsiness and sluggishness
• Common: dry mouth
• Common: unusual dreams, memory impairment
• Common: nausea
• Uncommon: dizziness
• Uncommon: dyspepsia

Special precautions

• Prescription medicine (verschreibungspflichtig) — dispensed strictly as directed by a doctor
• Tablets of any strength (1, 2 and 3 mg) must not be broken or crushed before use — the active substance has a bitter taste
• Long-term use may lead to physical and psychological dependence; the risk increases with dose and duration of the course, and after discontinuation «rebound» insomnia may occur for 1–2 nights
• Alcohol is strictly incompatible — it intensifies the sedative effect and the risk of dangerous sleep behaviour (sleepwalking, «sleep-driving»)
• Residual drowsiness is possible the next morning: at least 12 hours must pass between taking the medicine and driving or operating machinery
• Do not combine it with grapefruit juice or potent CYP3A4 inhibitors without consulting a doctor
• Not recommended during pregnancy and breastfeeding

Sources: www.fachinfo.de, www.gelbe-liste.de, www.gelbe-liste.de, www.gelbe-liste.de, www.rote-liste.de