20 Mar 2013

Stilnoct 5mg (zolpidem tartrate) - United Kingdom

Updated: 20 Mar 2013

Stilnoct 5mg Tablets

The short-term treatment of insomnia in situations where the insomnia is debilitating or is causing severe distress for the patient.

Stilnoct 5mg Description, Presentation and Dosage

Stilnoct 5mg Description

Stilnoct 5mg Drug Class Description

Imidazopyridine (GABA-A receptor modulator selective for omega-1 receptor subtype hypnotic agent).

Stilnoct 5mg Drug Description

Round white film coated tablets containing 5mg zolpidem tartrate.

Stilnoct 5mg Generic Name

zolpidem tartrate

Stilnoct 5mg Presentation

Stilnoct 5mg Presentation

Coated tablets for oral administration.

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Stilnoct 5mg Dosage

Stilnoct 5mg Adult Dosage

Route of administration: Oral

Zolpidem tartrate acts rapidly and therefore should be taken immediately before retiring, or in bed.

The recommended daily dose for adults is 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.

As with all hypnotics, long-term use is not recommended and a course of treatment should not exceed four weeks.

Special Populations

Children

Safety and effectiveness of zolpidem in paediatric patients under the age of 18 years have not been established. Therefore, zolpidem should not be prescribed in this population.

Elderly

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate therefore a 5mg 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 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.

Stilnoct 5mg Precautions, Reactions and Contraindications

Stilnoct 5mg Special Precautions

Stilnoct 5mg Special 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.

Specific Patient groups

Respiratory Insufficiency:

As hypnotics have the capacity to depress respiratory drive, precautions should be observed if zolpidem is prescribed to patients with compromised respiratory function.

Hepatic Insufficiency:

See section Dosage Information

Elderly:

See section Dosage Information.

Paediatric Patients:

Safety and effectiveness of zolpidem have not been established in patients below the age of 18 years. In an 8-week study in paediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD), psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse events observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations (7.4% vs. 0%). 

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:

Hypnotics such as Zolpidem are not recommended for the primary treatment of psychotic illness.

Depression:

As with other sedative/hypnotic drugs, zolpidem tartrate should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present therefore the least amount of zolpidem that is feasible should be supplied to these patients to avoid the possibility of intentional overdosage by the patient. Pre-existing depression may be unmasked during use of zolpidem. Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists.

General information relating to effects seen following administration of benzodiazepines and other hypnotic agents which should be taken into account by the prescribing physician are described below.

Tolerance:

Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents like zolpidem may develop after repeated use for a few weeks

Dependence:

Use of benzodiazepines or benzodiazepine-like agents like zolpidem may lead to the development of physical and psychological dependence. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of psychiatric disorders and/or alcohol or drug abuse.

These patients should be under careful surveillance when receiving hypnotics.

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches or muscle pain, extreme anxiety and tension, restlessness, confusion 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 or epileptic seizures.

Rebound insomnia:

A transient syndrome whereby the symptoms that led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of hypnotic treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness.

It is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur when the medicinal product is discontinued. Since the risk of withdrawal phenomena or rebound has been shown to be greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually where clinically appropriate.

There are indications that, in the case of benzodiazepines and benzodiazepine-like agents with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.

Amnesia:

Benzodiazepines or benzodiazepine-like agents such as zolpidem may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours.

Other psychiatric and "paradoxical" reactions:

Other psychiatric and paradoxical reactions like restlessness, exacerbated insomnia, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, abnormal behaviour and other adverse behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents. Should this occur, use of the product should be discontinued. These reactions are more likely to occur in the elderly.

Somnambulism and associated behaviours:

Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, making phone calls or having sex, with amnesia for the event, have been reported in patients who had taken zolpidem and were not fully awake. The use of alcohol and other CNS-depressants with zolpidem appears to increase the risk of such behaviours, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of zolpidem should be strongly considered for patients who report such behaviours (for example, sleep driving), due to the risk to the patient and others.

Stilnoct 5mg Adverse Reactions

Stilnoct 5mg Adverse Reactions

The following CIOMS frequency rating is used, when applicable:

Very common ≥10%

Common ≥ 1 and < 10%

Uncommon ≥ 0.1 and < 1%

Rare ≥0.01 and < 0.1%

Very rare < 0.01%

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. They should in theory be less if zolpidem tartrate is taken immediately before retiring, or in bed.

They occur most frequently in elderly patients.

Immune system disorders

Not known: angioneurotic oedema

Psychiatric disorders

Common: hallucination, agitation, nightmare

Uncommon: confusional state, irritability

Not known: restlessness, aggression, delusion, anger, psychosis, 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

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).

Stilnoct 5mg Contraindications

Stilnoct 5mg Contraindications

Zolpidem tartrate is contraindicated in patients with a hypersensitivity to zolpidem tartrate or any of the inactive ingredients, 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.

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