ZALZO

4). Treatment should be given for the shortest possible duration. Posology The treatment should be taken in a single intake and not be re-administered during the same night. The recommended daily dose for adults is 10 mg to be taken immediately at bedtime.

The lowest effective daily dose of zolpidem tartrate should be used and must not exceed 10 mg. 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.

Treatment should be as short as possible. It should not exceed four weeks including the period of tapering off. 4). Special populations Paediatric population Zalzo 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.

1. Elderly Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate therefore a 5 mg dose is recommended. These recommended doses should not be exceeded. Hepatic impairment As clearance and metabolism of zolpidem tartrate is reduced in hepatic impairment, dosage should begin at 5 mg in these patients with particular caution being exercised in elderly patients.

In adults (under 65 years) dosage may be increased to 10 mg only where the clinical response is inadequate and the drug is well tolerated. 3). Method of administration ZALZO should be taken orally, immediately at bedtime. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference.

01% Not known: cannot be estimated based on available data. There is evidence of a dose-relationship for adverse effects associated with zolpidem tartrate use, particularly for certain CNS and gastrointestinal events. 2, they should in theory be less if zolpidem tartrate is taken immediately before retiring, or in bed.

They occur most frequently in elderly patients. 4). Not known: drug tolerance Withdrawal syndrome. 4). Withdrawal symptoms vary and may include rebound insomnia, muscle pain, anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, panic attacks, muscle aches/cramps, gastrointestinal disturbances and irritability.

In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations. In very rare cases, seizures may occur.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 Like other sedative/hypnotic drugs, Zalzo has CNS-depressant effects. 5). Zolpidem tartrate should be taken in a single intake immediately at bedtime and not be re- administered during the same night.

Specific patient groups Respiratory insufficiency:

As hypnotics have the capacity to depress respiratory drive, precautions should be observed if Zalzo is prescribed to patients with compromised respiratory function. 2. 2 for dose recommendations.

Risk from concomitant use of opioids:

Concomitant use of Zalzo and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as zolpidem with opioids should be reserved for patients for whom alternative treatment options are not possible.

2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5).

Use in patients with a history of drug or alcohol abuse:

Extreme caution should be exercised when prescribing for patients with a history of drug or alcohol abuse. These patients should be under careful surveillance when receiving zolpidem tartrate or any other hypnotic, since they are at risk of habituation and psychological dependence.

Psychotic illness:

1. • Obstructive sleep apnoea. • Myasthenia gravis. • Severe hepatic insufficiency. • Acute and/or severe respiratory depression. In the absence of data, zolpidem tartrate should not be prescribed for children or patients with psychotic illness.