Each scored film-coated tablet contains:
Zolpidem tartrate .................................................. 10 mg
White, oblong, film-coated scored tablets.
Indications are limited to treatment of severe sleep disorders in the
• Transient insomnia.
Posology and method of administration
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
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
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.
This medicinal product should never be used in the following situations:
• hypersensitivity to the active substance or any of the ingredients in the
• severe respiratory insufficiency,
sleep apnoea syndrome,
severe, acute or chronic hepatic insufficiency (risk of encephalopathy),
due to the lactose content, this medicinal product is contraindicated in the
event of congenital galactosaemia, glucose or
galactose malabsorption syndrome or
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.
Due to the lactose content, this medicinal product is contraindicated in the
event of congenital galactosaemia, glucose or galactose malabsorption
syndrome or lactase deficiency.
After repeated administration ever several weeks, the sedating or hypnotic
effect of benzodiazepines and related substances may gradually decrease.
Any administration of benzodiazepines and related substances, particularly
use, may induce the development of physical or psychic drug dependence.
Several factors appear to favour onset of drug dependence:
history of dependence to other drugs (medicinal products or net), and
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
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
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.
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
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.
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,
hallucinations, oniric delirium, psychotic symptoms,
• disinhibition with
• euphoria, irritability,
This syndrome may be accompanied by disorders that could be potentially
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
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).
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
section Pharmacokinetic properties).
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
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.