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Stilnox

COMPOSITION
Each scored film-coated tablet contains:
Zolpidem tartrate .................................................. 10 mg

PHARMACEUTICAL FORM
White, oblong, film-coated scored tablets.

CLINICAL PARTICULARS
Therapeutic indications
Indications are limited to treatment of severe sleep disorders in the following cases:
Occasional insomnia,

Transient insomnia.

Posology and method of administration

Oral route.

Dose
The treatment should always be implemented at the lowest effective dose and maximum dosage never exceeded.
The usual dose for adults is one 10-mg tablet daily.
The medicinal product should always be taken just before going to bed.
In elderly subjects or subjects presenting with hepatic insufficiency: dosage should be halved, i.e. 5 mg.
Dosage must never exceed 10 mg per day.
Safety and effectiveness of zolpidem in paediatric patients under the age of 18 years have not been established. Therefore, STILNOX should not be prescribed in this population.
STILNOX can be prescribed either continuously or on demand, depending on the patient's symptoms.

Treatment duration
The treatment period should be as short as possible, from a few days to four weeks, including the tapering period (see section Special warnings and special precautions for use).
The patient should be advised to take the treatment as fellows:

2 to 5 days for occasional insomnia (e.g. during a trip)
2 to 3 weeks for transient insomnia (e.g. during a troubled period).
Very short treatment periods do not require any gradual treatment discontinuation.
For certain patients, it may be necessary to continue treatment for longer than four weeks, in which case careful and repeated reassessment of the patient's condition is necessary.

Contraindications
This medicinal product should never be used in the following situations:

hypersensitivity to the active substance or any of the ingredients in the product,

severe respiratory insufficiency,
sleep apnoea syndrome,
severe, acute or chronic hepatic insufficiency (risk of encephalopathy),

myasthenia.
due to the lactose content, this medicinal product is contraindicated in the event of congenital galactosaemia, glucose or galactose malabsorption syndrome or lactase deficiency.

Special warnings and special precautions for use

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling) which can occur as early as the first time the product is taken.

Special warnings
Due to the lactose content, this medicinal product is contraindicated in the event of congenital galactosaemia, glucose or galactose malabsorption syndrome or lactase deficiency.

PHARMACOLOGICAL TOLERANCE
After repeated administration ever several weeks, the sedating or hypnotic effect of benzodiazepines and related substances may gradually decrease.

DRUG DEPENDENCE
Any administration of benzodiazepines and related substances, particularly prolonged use, may induce the development of physical or psychic drug dependence. Several factors appear to favour onset of drug dependence:
treatment duration,
dosage,
history of dependence to other drugs (medicinal products or net), and alcohol.

Drug dependence may appear at therapeutic dose levels and/or in patients not presenting with individual risk factors.

Exceptional cases of drug dependence have been reported for therapeutic doses of zolpidem.
This state of dependence can produce withdrawal syndrome when treatment is discontinued.
Some symptoms are frequent and appear commonplace: insomnia, headaches, marked anxiety, myalgia, muscle tension and irritability. Other symptoms are rarer: agitation or even confusion, paresthesia of fingers and toes, hyper-reactivity to light, sound and physical contact, depersonalisation, derealisation, hallucinations and convulsions.
Withdrawal symptoms may appear during the days following treatment discontinuation. With short-acting benzodiazepines, certain withdrawal symptoms may occur between two consecutive intakes, especially at high doses.
Whatever the anxiolytic or hypnotic indication, the combination of several benzodiazepines is liable to increase the risk of drug dependence. Cases of drug abuse have been reported.

REBOUND INSOMNIA
This transient syndrome is a worsening of the initial insomnia for which the benzodiazepines and related substances were prescribed.

AMNESIA AND IMPAIRED PSYCHOMOTOR FUNCTION
Anterograde amnesia and impaired psychomotor function may occur within hours of intake.
To reduce these risks, the product should be taken just before going to bed, or even in bed (see section Posology and method of administration), and in optimal conditions for uninterrupted steep of 7-8 hours.

BEHAVIOUR DISORDERS
In certain subjects, benzodiazepines and related substances may induce a syndrome that combines impaired consciousness and behaviour and memory disorders at varying degrees.
The following may be observed:
worsening of insomnia, nightmares, agitation, nervousness,

delirium, hallucinations, oniric delirium, psychotic symptoms,

disinhibition with impulsiveness,

euphoria, irritability,
anterograde amnesia,

suggestibility.

 

This syndrome may be accompanied by disorders that could be potentially dangerous for the patient and ethers, such as:
unusual patient behaviour patterns,
aggressiveness to self and others, especially if the patient is prevented front doing something he/she wants to do,
automatic behaviour with post-event amnesia.

 

If these symptoms occur, treatment should be discontinued.
These symptoms are more often observed in elderly subjects.

SOMNAMBULISM AND ASSOCIATED BEHAVIOURS
Sleep walking associated with other behavior such as night lime driving, cooking and eating, using the telephone or engaging in sexual intercourse, with subsequent amnesia, has been reported in patient, who had taken zolpidem and were net fully awake.

The use of alcohol and other central nervous system depressants with zolpidem seems is to increase the risk of such behavior, as does administration of zolpidem at doses higher than the maximum recommended dose.

Discontinuation of zolpidem treatment is strongly recommended in patients who have experienced such behavior (see Interaction with other medicinal products and other forms of interaction, and Undesirable effects).

ACCUMULATION RISK
Benzodiazepines and related substances (like all medicinal products) remain in the body for a period of about five half-lives (see section Pharmacokinetic properties). In elderly patients or patients presenting with renal or hepatic insufficiency, half-life may be significantly longer. After repeated administration, the medicinal product or its metabolites reach steady state much later and with much higher levels. It is only possible to evaluate the efficacy and safety of the medicinal product at steady state.

Dose adjustment may be required (see section Posology and method of administration). Given the metabolic route of zolpidem, this is not expected in the event of renal insufficiency (see section Pharmacokinetic properties).

ELDERLY SUBJECTS
Great care must be taken when prescribing benzodiazepines and related substances to elderly subjects, because of the risk of sedation and/or muscle relaxant effects which may lead to falls with serious consequences in this population.

Special precautions for use
Very great care is required in the event of history of alcoholism or drug addiction (medicinal products or not) (see section Interactions with other medicinal products and other forms of interaction).
In alt cases, insomnia must systematically be assessed and its causes treated before a hypnotic is prescribed.
Insomnia may be related to an underlying physical or psychiatric disorder. Persistence or worsening of insomnia after a short treatment period requires further clinical assessment.

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