Zodium Scored Film Coated Tablets
Zolpidem tartrate 10mg
Usage and indications:
Zodium is indicated for short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.
Dosage and administration:
The treatment should be taken in a single intake and not be re-administered during the same night.
The recommended daily dose for adult men is 10mg and your adult woman is 5 mg, to be taken immediately at bedtime. The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg.
As with all hypnotics, long-term use is not recommended and a course of treatment should not exceed four weeks. The duration of treatment should usually vary from a few days to two weeks with a maximum of four weeks including tapering off where clinically appropriate. In certain cases extension beyond the maximal treatment period may be necessary; if so, this should not take place without re-evaluation of the patient's status.
Paediatric population: Zolpidem is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group.
Elderly: Elderly or debilitated patients may be especially sensitive to the effects of zolpidem therefore a 5mg dose is recommended. These recommended doses should not be exceeded.
Hepatic impairment: As clearance and metabolism of zolpidem is reduced in hepatic impairment, dosage should begin at 5mg in these patients with particular caution being exercised in elderly patients. In adults (under 65 years) dosage may be increased to 10mg only where the clinical response is inadequate and the drug is well tolerated.
Immune system disorders:
Not known: angioneurotic oedema.
Common: hallucination, agitation, nightmare
Uncommon: confusional state, irritability
Not known: restlessness, aggression, delusion, anger, psychoses, abnormal behaviour, somnambulism, dependence (withdrawal symptoms, or rebound effects may occur after treatment discontinuation), libido disorder, depression.
Most of these psychiatric undesirable effects are related to paradoxical reactions.
Nervous system disorders:
Common: somnolence, headache, dizziness, exacerbated insomnia, anterograde amnesia: (amnestic effects may be associated with inappropriate behaviour).
Not known: depressed level of consciousness.
Respiratory, thoracic and mediastinal disorders:
Not known: respiratory depression.
Common: diarrhoea, nausea, vomiting, abdominal pain.
Not known: Liver enzymes elevated.
Skin and subcutaneous tissue disorders:
Not known: rash, pruritus, urticaria, hyperhidrosis.
Musculoskeletal and connective tissue disorders:
Common: back pain.
Not known: muscular weakness.
Infections and infestations:
Common: upper respiratory tract infection, lower respiratory tract infection
General disorders and administration site conditions:
Not known: gait disturbance, drug tolerance, fall (predominantly in elderly patients and when zolpidem was not taken in accordance with prescribing recommendation).
Warnings and precautions:
The cause of insomnia should be identified wherever possible and the underlying factors treated before a hypnotic is prescribed. The failure of insomnia to remit after a 7-14 day course of treatment may indicate the presence of a primary psychiatric or physical disorder, and the patient should be carefully re-evaluated at regular intervals.
Next–day psychomotor impairment
The risk of next-day psychomotor impairment, including impaired driving ability, is increased if:
• zolpidem is taken within less than 8 hours before performing activities that require mental alertness
• a dose higher than the recommended dose is taken;
• zolpidem is co-administered with other CNS depressants or with other drugs that increase the blood levels of zolpidem, or with alcohol or illicit drugs.
Zolpidem should be taken in a single intake immediately at bedtime and not be re-administered during the same night.
Pack: carton box containing (AL/PVC) strip of 10 scored film coated tablets.