Zolpidem Tartrate Teva

Company: Teva Pharmaceuticals Ireland.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Zolpidem (tartrate) 5mg, 10mg.
Description: White, oval, biconvex, film-coated tablets marked ZIM on one side and 5 on reverse or ZIM10 on one side, resp.
Presentation: 5mg-28, €1.32; 10mg-28, €2.64.
Indication: Short term treatment of insomnia.

Pharmacology: Zolpidem is a non-benzodiazepine hypnotic agent of the imidazopyridine class. Its effects are related to a specific agonist action at central receptors belonging to the GABA-omega (BZ1 and BZ2) macromolecular receptor complex, modulating the opening of the chloride ion channel. Zolpidem acts primarily upon omega (BZ1) receptor subtypes.
Dosage: Adult: 10mg with fluid immediately before bed. Duration should be as short as possible, maximum 4 weeks (including tapering off). Hepatic insufficiency: 5mg; maximum 10mg. Elderly: 5mg; maximum 10mg. Children: Under 18 years, contraindicated.
Contraindications: Hypersensitivity to zolpidem or to any of the excipients. Severe hepatic or respiratory insufficiency, sleep apnoea syndrome, myasthenia gravis. Pregnancy, lactation.
Special precautions: Identify cause of insomnia wherever possible and treat underlying factors before a hypnotic is prescribed. Caution: History of psychiatric disorders, alcohol or drug abuse (monitor closely), elderly, renal or chronic respiratory insufficiency, depression. Psychotic illness (not recommended). Discontinue if somnambulism and associated behaviours or adverse behavioural effects occur. Tolerance, dependence and rebound insomnia may occur. Withdraw gradually. Amnesia may occur; patients should ensure they have 7-8 hours of uninterrupted sleep.  Driving/using machines. Contains lactose.
Drug interactions: Not recommended: Alcohol. Caution: CNS depressants, antipsychotics, hypnotics, anxiolytics/sedatives, muscle relaxants, antidepressants, narcotic analgesics, antiepileptics, anaesthetics, sedative antihistamines, strong cytochrome P450 inducers, CYP3A4 inhibitors.
Adverse drug reactions: Hallucination, agitation, nightmare, somnolence, drowsiness the following day, numbed emotions, reduced alertness, headache, dizziness, anterograde amnesia (inappropriate behaviour), ataxia, exacerbated insomnia, vertigo, GI upset, fatigue.
Full prescribing information and references available from Teva Pharmaceuticals Ireland. Telephone: 1800 201700.