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.  

Special Populations

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.    

Undesirable effects:

Immune system disorders:

Not known: angioneurotic oedema.

Psychiatric disorders:

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.

Eye disorders:

Uncommon: diplopia

Respiratory, thoracic and mediastinal disorders:

Not known: respiratory depression.

Gastro-intestinal disorders:

Common: diarrhoea, nausea, vomiting, abdominal pain.

Hepatobiliary disorders:

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:

Common: fatigue

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:

  • Use the lowest effective dose for the patient.
  • The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening.
  • The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
  • If the 5 mg dose is not effective, the dose can be increased to 10 mg.
  • In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness.
  • Complex sleep-related behaviours have been reported in patients who got out of bed after taking a sedative-hypnotic and were not fully awake, including sleep-driving, preparing and eating food, making phone calls, leaving the house, etc. Patients usually do not remember these events. Although complex sleep-related behaviours may occur with these drugs when taken alone at therapeutic doses, the use of alcohol and other CNS-depressants concomintantly appears to increase the risk of such behaviours, as does the use of these drugs at doses exceeding the maximum recommended dose.
  • Due to the risk to the patient and the community, discontinuation of Zodium should be strongly considered for patients who report any such complex sleep-related behaviour.
  • The use of these drugs in patients with other disorders known to affect sleep and induce frequent awakenings (e.g. sleep apnea, Periodic Limb Movement Disorder, Restless Legs Syndrome) is discouraged, as they may be also at increased risk of complex sleep-related behaviours.
  • Due to the risk to the patient and the community, discontinuation of Zodium should be strongly considered for patients who report any such complex sleep-related behaviour.
  • Caution should be exercised with concomitant use of potent CYP3A4 inhibitors.
  • Continuous use of these drugs is limited to a short duration.
  • Depression: Worsening of depression or, suicidal thinking may occur.

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.

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