Stilnox Tablets Uses, Dosage, Side Effects, Precautions

Important to know about Stilnox Tablets ?

Stilnox Tablets indication and Uses :

Stilnox Uses, Dosage, Side Effects, Precautions

Stilnox Tablets Uses, Dosage, Side Effects, Precautions

Indications are limited to severe sleep disorders in adults in the following cases:

·         Occasional insomnia,

·         Transient insomnia.

Stilnox Tablets Dosage :

Oral way.

Dose

In all cases, treatment will be initiated at the lowest effective dose and the maximum dose will not be exceeded.

The usual dose in adults is 1 tablet at 10 mg per day.

Stilnox Tablets acts quickly, taking should take place immediately before bedtime.

Elderly or weakened subjects

Elderly or frail subjects are particularly sensitive to the effects of zolpidem, the recommended dosage in this population is 5 mg (ie ½ tablet).

Hepatic insufficiency

The elimination and metabolism of zolpidem is decreased in cases of hepatic insufficiency, treatment should be initiated in these patients at the dosage of 5 mg per day, paying particular attention in the elderly.

In all cases, the dosage should not exceed 10 mg per day.

The safety and efficacy of zolpidem has not been demonstrated in patients under 18 years of age. Therefore, zolpidem should not be prescribed in this population (see section 5.1 ).

Stilnox Tablets can be prescribed, either continuously or on demand, depending on the patient’s symptomatology.

duration

Treatment should be as short as possible, from a few days to 4 weeks, including the dose reduction period (see Warnings and Precautions ).

The duration of treatment should be presented to the patient:

· 2 to 5 days in case of occasional insomnia (as for example during a trip),

· 2 to 3 weeks in case of transient insomnia (as during the occurrence of a serious event).

Very short treatments do not require a progressive stop.

In some cases, it may be necessary to prolong the treatment beyond the recommended periods. This requires accurate and repeated assessments of the patient’s condition.

How it works Stilnox Tablets :

Pharmacotherapeutic group: hypnotic and sedative, ATC code: N05CF02 (N: central nervous system) .

Zolpidem is a benzodiazepine-like hypnotic imidazopyridine and has a qualitatively similar pharmacodynamic activity to that of other compounds of this class:

·         Muscle relaxant,

·         Anxiolytic,

·         Sedative,

·         Hypnotic,

·         Anticonvulsant,

·         Amnesia.

Experimental studies have shown a sedative effect at doses lower than the doses required to achieve anticonvulsant, muscle relaxant or anxiolytic effects.

These effects are related to a specific agonist action on a central receptor belonging to the complex “GABA-OMEGA macromolecular receptors”, also called BZ1 and BZ2 and modulating the opening of the chlorine channel.

Zolpidem preferentially binds to the omega 1 subtype (or BZ1).

In humans, zolpidem shortens the time to fall asleep, reduces the number of nocturnal awakenings, increases the total sleep time and improves the quality. These effects are associated with a characteristic electroencephalographic profile, different from that of benzodiazepines. Sleep recording studies have shown that zolpidem prolongs stage II as well as deep sleep stages (III and IV). At the recommended dosage, zolpidem has no influence on the total duration of paradoxical sleep (REM).

Randomized trials have only demonstrated the efficacy of zolpidem at a dose of 10 mg.

In a randomized, double-blind study in 462 healthy volunteers aged <65 years with transient insomnia, zolpidem at the 10 mg dose decreased the mean time to sleep by 10 minutes compared with placebo, compared to 3 minutes for zolpidem used at a dose of 5 mg.

In a randomized, double-blind study in 114 patients with chronic insomnia aged less than 65 years, zolpidem at the 10 mg dose decreased the mean time to sleep by 30 minutes compared to placebo, compared to 15 minutes for zolpidem used at the dose of 5 mg.

In some patients, a dose of 5 mg may be effective.

Child and teenager

One randomized controlled trial versus placebo conducted in a population of 201 children and adolescents aged 6 to 17 years with insomnia associated with attention deficit disorder / hyperactivity disorder (ADHD) has not demonstrated efficacy of zolpidem in the dose of 0.25 mg / kg / day (with a maximum of 10 mg / day) compared to placebo. Psychiatric and neurological disorders were the most frequently observed adverse events in patients treated with zolpidem compared to placebo, including vertigo (23.5% versus 1.5%), headache (12.5% versus 9 %) , 2%) and hallucinations (7.4% versus 0%).

Therefore, and in the absence of new studies, zolpidem should not be prescribed in this population (see section 4.2 ).

Stilnox Tablets Side Effects

Stilnox Tablets Side Effects

Stilnox Tablets Side Effects :

Like all medicines, this medicine can cause side effects, although not everybody gets them.

They depend on the ingested dose and your own sensitivity.

The following side effects occur frequently (1 to 10 people in 100):

· Agitation,

· Nightmares,

· Hallucinations,

· Decreased alertness or drowsiness (especially in the elderly),

· Insomnia,

· Feelings of divinity,

· Headache,

· Loss of memory regarding events occurring during treatment (anterograde amnesia). This effect can occur at the doses prescribed by your doctor. The risk increases proportionally with the dose,

· Diarrhea,

· Nausea,

· Vomiting,

· Abdominal pain,

· Fatigue,

· Respiratory tract infections.

The following side effects occur infrequently (1 to 10 people in 1000):

· Tingling sensation in the hands and feet (paresthesia),

· Tremors,

· Confusion,

· Irritability,

· Double vision,

· Blurred vision,

· Appetite disorders,

· Joint pain,

· Muscle pain,

· Muscular contractions.

The following side effects occur very rarely (fewer than 1 in 10,000 people):

· Vision impairment (visual impairment).

The following side effects may occur but their frequency is unknown:

· Sudden swelling of the face and / or neck that may cause difficulty breathing and endangering the patient (Quincke’s edema),

· Behavioral disorders,

· Alteration of the state of consciousness,

· Attention or speech disorders,

· Aggression,

· Nervousness,

· Delirium,

· Anger,

· Sleepwalking,

· Physical and mental dependence even at doses recommended by your doctor, withdrawal syndrome or insomnia rebound at the end of treatment (see also the sections “Risk of dependence” and “Risk of rebound”),

· Depression,

· Change in libido,

· Excitement (euphoric mood),

· Difficulty coordinating certain movements,

· Tension,

· Difficulty breathing,

· Rashes on the skin,

· Itching,

· Red patches on the skin itching (hives)

· Muscle weakness,

· Falls,

· Increased liver enzymes, liver damage.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website: www.ansm.sante.fr

By reporting side effects, you can help provide more information on the safety of the medicine.

Stilnox Tablets Interactions :

hypnotics

The currently prescribed hypnotics are either benzodiazepines and related (zolpidem, zopiclone) or H1 antihistamines. In addition to increased sedation when prescribed with other CNS depressant drugs, or in case of alcohol consumption, benzodiazepines should also be considered for the possibility of increasing the respiratory depressant effect. they are associated with morphinomimetics, other benzodiazepines, or phenobarbital, especially in the elderly.

Central nervous system depressant drugs

It must be taken into account that many drugs or substances can add their depressant effects of the central nervous system and help reduce alertness. These are morphine derivatives (analgesics, antitussives and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (eg meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin , mianserine, mirtazapine, trimipramine), sedative H1 antihistamines, central antihypertensives, baclofen, thalidomide, antiepileptics and anesthetics.

Associations advised against

+ Alcohol (drink or excipient)

Alcohol enhancement of the sedative effect of benzodiazepines and the like. Impairment of alertness can make driving and using machines dangerous.

Avoid taking alcoholic drinks and drugs containing alcohol.

+ Fluvoxamine

Concomitant administration of fluvoxamine may increase the blood level of zolpidem. Simultaneous use is not recommended.

+ Inhibitors and inducers of CYP 450

Concomitant administration of ciprofloxacin may increase the blood level of zolpidem. Simultaneous use is not recommended.

Associations subject to precautions for use

+ Rifampicin

Decreased plasma concentrations and efficacy of zolpidem by increasing its hepatic metabolism. Clinical surveillance. Maybe use another hypnotic.

Associations to consider

+ Other central nervous system depressants

Possible increase in somnolence and impairment of psychomotor functions the day after taking. Impairment of alertness can make driving and using machines dangerous (see Warnings and Precautions and Effects on the ability to drive and use machines ).

Isolated cases of visual hallucination have been reported in patients taking zolpidem in combination with antidepressants such as bupropion, fluoxetine, sertraline and venlafaxine.

+ Barbiturates, morphine:

Increased risk of respiratory depression, which can be fatal in case of overdose.

+ Buprenorphine

With buprenorphine used in substitution therapy: increased risk of respiratory depression that can be fatal. Carefully evaluate the benefit / risk ratio of this combination. Inform the patient of the need to respect the prescribed doses.

+ Clozapine

Increased risk of collapse with respiratory and / or cardiac arrest.

+ Clarithromycin, erythromycin, telithromycin

Slight increase in sedative effects of zolpidem.

+ Ketoconazole, itraconazole, voriconazole

Slight increase in sedative effects of zolpidem.

+ Nelfinavir, protease inhibitors boosted with ritonavir

Slight increase in sedative effects of zolpidem.

No significant pharmacokinetic interaction was observed with zolpidem with ranitidine.

Stilnox Tablets Warnings and Precautions :

Stilnox Tablets Warnings and Precautions

Stilnox Tablets Warnings and Precautions

Warnings

This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

PHARMACOLOGICAL TOLERANCE

The sedative or hypnotic effect of benzodiazepines and related substances may decrease gradually despite the use of the same dose when administered for several weeks.

ADDICTION

Any treatment with benzodiazepines and related drugs, especially with prolonged use, may result in a state of physical and mental dependence.

Various factors seem to favor the occurrence of dependence:

· Duration of treatment,

· Dose,

· History of other drug addictions, including alcoholic.

Drug dependence may occur at therapeutic doses and / or in patients without individualized risk factors.

With zolpidem, this state of dependence has been reported exceptionally at therapeutic doses.

This state can lead to the cessation of treatment a withdrawal phenomenon.

Some symptoms are common and seemingly trivial: insomnia, headache, severe anxiety, myalgia, muscle tension, irritability.

Other symptoms are more rare: agitation or even confusional episode, paresthesia of the extremities, hyperreactivity to light, noise, and physical contact, depersonalization, derealization, hallucinatory phenomena, convulsions.

Withdrawal symptoms may occur within days of stopping treatment. For short-acting benzodiazepines, and especially if given at high doses, symptoms may even occur in the interval between two doses.

The combination of several benzodiazepines may, regardless of the anxiolytic or hypnotic indication, increase the risk of drug dependence.

Cases of abuse have been reported.

REBOUND PHENOMENON

This transient syndrome may manifest itself as an exacerbation of insomnia that motivated treatment with benzodiazepines and the like.

ALTERATIONS OF PSYCHOMOTRIC FUNCTIONS

Alterations in psychomotor functions are likely to appear within hours of taking.

The risk of impaired psychomotor functions, including the ability to drive, increases in the following situations:

· Take this medicine less than 8 hours before performing any activity that requires alertness (see section 4.7);

· Taking a dose higher than the recommended dose;

· Coadministration with other central nervous system depressants, other drugs that increase blood concentrations of zolpidem, or with alcohol or illicit substances (see section 4.5).

Zolpidem should be taken as a single dose immediately at bedtime and should not be re-administered during the same night.

AMNESIA

Anterograde amnesia is likely to appear within hours of taking.

To reduce these risks, patients should ensure that they can have an uninterrupted sleep period of 8 hours.

BEHAVIORAL DISORDERS

In some subjects, benzodiazepines and related products may lead to a syndrome associating to varying degrees an alteration of the state of consciousness and behavior and memory disorders.

Can be observed:

· Exacerbated insomnia, nightmares, agitation, nervousness,

· Delusions, hallucinations, confuso-oniric state, psychotic type symptoms,

· Disinhibition with impulsiveness,

· Euphoria, irritability,

· Anterograde amnesia,

· Suggestibility.

This syndrome may be accompanied by potentially dangerous disorders for the patient or for others, such as:

· Unusual behavior for the patient,

· Self- or hetero-aggressive behavior, especially if the family is trying to interfere with the patient’s activity,

· Automatic driving with post-event amnesia.

These events require the cessation of treatment.

SOMNAMBULISM AND ASSOCIATED BEHAVIORS

Complex behaviors such as night driving (ie driving a vehicle without being fully awake after taking a sedative-hypnotic) with post-event amnesia have been reported in patients who have taken zolpidem. Although somnambulism-related behaviors may occur during zolpidem monotherapy at therapeutic doses, the associated intake of alcohol and other central nervous system depressants appears to increase the risk of such behavior as well as zolpidem at doses higher than the maximum recommended dose.

Because of the risk to the patient and those around him, stopping zolpidem is recommended in patients with sleep-related disorders .

RISK OF ACCUMULATION

Benzodiazepines and related drugs (like all drugs) persist in the body for a period of about 5 half-lives .

In the elderly or those suffering from renal or hepatic insufficiency, the half-life may be considerably longer. When taken repeatedly, the drug or its metabolites reach the equilibrium plateau much later and at a much higher level. It is only after obtaining a balance plateau that it is possible to evaluate both the efficacy and the safety of the drug.

Dosage adjustment may be necessary .

This is not expected with zolpidem in renal failure, given its metabolism .

SUBJECT AGE

Benzodiazepines and related products should be used with caution in the elderly, because of the risk of sedation and / or muscle relaxant effects that may be associated with falls, with often severe consequences in this population, and because of the increased frequency. important behavioral disorders.

INSUFFICIENT HEPATIC

The risk of accumulation leads to dose adjustment .

Zolpidem should not be used in patients with severe hepatic impairment as this may result in encephalopathy (see sections 4.2 Posology and method of administration, 4.3 Contraindication and 4.8 Undesirable effects).

Special precautions for use

Great caution is recommended in case of a history of alcoholism or other addictions, whether medicated or not.

In all cases, the evaluation of insomnia must be systematically performed, and its causes treated, before the prescription of a hypnotic.

Insomnia may reveal an underlying physical or psychiatric disorder. The persistence or worsening of insomnia after a short period of treatment necessitates a reassessment of the clinical diagnosis.

DURATION OF THE TREATMENT

It should be clearly stated to the patient, depending on the type of insomnia .

SUICIDE – DEPRESSION – MAJOR DEPRESSIVE EPISODE

Several epidemiological studies have shown an increase in the incidence of suicides and suicide attempts among depressed and non-depressed patients treated with benzodiazepines and other hypnotics, including zolpidem. The causal link is not established.

Insomnia may be one of the symptoms of depression, it must be treated. If insomnia persists, the patient should be reassessed.

In the subject presenting a major depressive episode:

Benzodiazepines and related drugs should not be prescribed alone as they allow depression to progress on its own account with persistence or increased suicidal risk.

Since the risk of suicide is present in these patients, the smallest amount of zolpidem must be made available to these patients (prescription and dispensing) in order to limit the possibility of an intentional overdose.

PROGRESSIVE STOPPING PROCEDURES FOR TREATMENT

They must be stated to the patient precisely.

In addition to the need for gradual decrease in doses, patients should be warned of the possibility of a rebound phenomenon, to minimize insomnia that may result from symptoms related to this interruption, even progressive.

The patient must be warned of the possibly uncomfortable nature of this phase.

CHILD

The use of Stilnox Tablets is not recommended in children in the absence of studies.

SUBJECT AGE

The risk of accumulation leads to dose adjustment (see section 4.2).

INSUFFICIENT RESPIRATORY

In patients with respiratory insufficiency, the depressant effect of benzodiazepines and related substances should be taken into account (especially since anxiety and agitation may be signs of a call for a decompensation of the respiratory function which justifies the transition to intensive care unit).

Drive and use machines:

Prevent drivers of vehicles and machine users from the risk of drowsiness.

Combination with other sedating medicinal products should be discouraged or taken into account when driving or using machines (see section Interactions with other medicinal products and other forms of interaction ).

If sleep time is insufficient, the risk of impaired alertness is further increased.

Stilnox Tablets and PREGNANCY / BREAST FEEDING / FERTILITY:

Prevent drivers of vehicles and machine users from the risk of drowsiness.

Combination with other sedating medicinal products should be discouraged or taken into account when driving or using machines (see section Interactions with other medicinal products and other forms of interaction ).

If sleep time is insufficient, the risk of impaired alertness is further increased.

What should I do if I miss a dose?

Take the next dose at the usual time the next day. Do not take a double dose to make up for the single dose you forgot to take.

What happens if I overdose from Stilnox Tablets ?

Immediately consult your doctor or pharmacist.

What is  Forms and Composition Stilnox Tablets?

FORMS and PRESENTATIONS

Breakable film-coated tablet:  Cases of 7 and 14, under pads.

Hospital model: Box of 150.

COMPOSITION
  p cp
Zolpidem (DCI) tartrate 10 mg

Excipients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch, hypromellose, magnesium stearate. Film coating :hypromellose, suspension of titanium dioxide, macrogol 400.
Excipient with known effect: lactose.

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