Zolpidem Sandoz

Description

What is zolpidem Sandoz?

ZOLPIDEM SANDOZ  is used to initiate and maintain sleep in those with sleeping difficulties, also called insomnia in patients over 18 years of age. It is not recommended for use for more than 4 weeks at a time. ZOLPIDEM SANDOZ has a different chemical structure to other sleeping tablets.

Zolpidem Sandoz 10mg

Tablets: Contains 10mg Zolpidem Sandoz (equals Zolpidem 8.03mg).
Excipients/Inactive Ingredients: Lactose H₂O, Cellulose microcrystalline, Sodium starch glycollate (type A), Colloidal silicon dioxide, Succinic acid, Magnesium stearate.
Film coating: Lactose monohydrate, Hydroxypropyl methyl cellulose (2910; 15cP), Titanium dioxide (E171), Macrogol 400.

Action

Pharmacology: Toxicology: Preclinical safety data.

Indications/Uses

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

Dosage/Direction for Use

Route of administration: Oral.
The treatment should be taken one tine intake only and not be re-administered during the same night.
The recommended daily dose for adults is 10 mg to be  taken immediately when he is going to bed. The lowest effective daily dose of Zolpidem Sandoz  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.
As with all hypnotics, long-term use is not recommended and a course of treatment should not exceed four weeks.
The recommended initial dose is 5mg for women and either 5mg or 10mg for men, taken only once per night immediately before going to bed with at least 8 hours remaining before the planned time of awakening.
If the 5mg dose is not effective, the dose can be increased to 10mg. In some patients, the higher morning blood levels following use of the 10mg dose increase the risk of next day you are not suppose to drive either car, motocycle  and other activities that require full alertness.
Use the lowest effective dose for the patient.
The total dose of zolpidem should not exceed 10mg once daily immediately before bedtime.
Special Populations: Pediatric population: Zolpidem Sandoz is not recommended for use in children and adolescents below 18 years of age, due to the secondary effects that these children might have.
Elderly: Elderly or debilitated patients may be especially sensitive to the effects of Zolpidem Sandoz therefore a 5mg dose is recommended. These recommended doses should not be exceeded. The recommended dose of zolpidem in elderly patients is 5mg once daily immediately before getting to bed.
Hepatic impairment: As clearance and metabolism of Zolpidem Sandoz is reduced in hepatic impairment, dosage should begin at 5mg in these patients with particular caution being exercised in elderly patients. In adults (below 65 years ) dosage may be increased to 10mg only where the clinical response is inadequate and the drug is well tolerated by the patient.
The recommended dose of zolpidem in patients with hepatic insufficiency is 5mg once daily immediately before bedtime.
Zolpidem must  not be used in patients with severe hepatic impairment as it may contribute to encephalopathy .

Overdosage

Signs and Symptoms: In cases of overdose involving Zolpidem Sandoz alone or with other CNS-depressant agents (including alcohol), impairment of consciousness ranging from somnolence to coma, and more severe symptomatology, including fatal outcomes have been reported.
Management: General symptomatic and supportive measures should be used. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Sedating drugs should be withheld even if excitation occurs.
Use of flumazenil may be considered where serious symptoms are observed.
Flumazenil is reported to have an elimination half-life of about 40 to 80 minutes. Patients should be kept under close observation because of this short duration of action; further doses of flumazenil may be necessary. However, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions).
Zolpidem is not dialyzable.
The value of dialysis in the treatment of an overdose has not been determined. Dialysis in patients with renal failure receiving therapeutic doses of zolpidem have demonstrated no reduction in levels of zolpidem.
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.

Contraindications

Zolpidem Sandoz is contraindicated in patients with a hypersensitivity to Zolpidem Sandoz or any of the inactive ingredients, obstructive sleep apnea, myasthenia gravis, severe hepatic insufficiency, acute and severe respiratory depression. In the absence of data, Zolpidem Sandoz should not be prescribed for children or patients with psychotic illness.

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 check at regular intervals.
This product is potential to cause severe allergic reactions and complex sleep-related behaviors.
Next-day psychomotor impairment: The risk of next-day psychomotor impairment, including impaired driving ability, is increased if: Zolpidem Sandoz is taken within less than 8 hours before performing activities that require mental alertness

A dose higher than the recommended dose is taken.
Zolpidem Sandoz is co-administered with other CNS depressants or with other drugs that increase the blood levels of Zolpidem Sandoz, or with alcohol or illicit drugs .

Zolpidem Sandoz 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 Zolpidem Sandoz is prescribed to patients with compromised respiratory function.
Hepatic Insufficiency: See Dosage & Administration.
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 Sandoz or any other hypnotic, since they are at risk of habituation and psychological dependence.
Psychotic illness: Hypnotics such as Zolpidem Sandoz are not recommended for the primary treatment of psychotic illness.
Depression: As with other sedative/hypnotic drugs, Zolpidem Sandoz should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present therefore the least amount of Zolpidem Sandoz 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 Sandoz. 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 Sandoz may develop after repeated use for a few weeks.
Dependence: Use of benzodiazepines or benzodiazepine-like agents like Zolpidem Sandoz 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 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: derealization, depersonalization, 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 minimizing 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 Sandoz may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product. In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see Adverse Reactions).
Other psychiatric and “paradoxical” reactions: Other psychiatric and paradoxical reactions like restlessness, exacerbated insomnia, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, abnormal behavior and other adverse behavioral 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 behaviors: Sleep walking and other associated behaviors 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 Sandoz and were not fully awake. The use of alcohol and other CNS-depressants with Zolpidem Sandoz appears to increase the risk of such behaviors, as does the use of Zolpidem Sandoz at doses exceeding the maximum recommended dose. Discontinuation of Zolpidem Sandoz should be strongly considered for patients who report such behaviors (for example, sleep driving), due to the risk to the patient and others (See Interactions and Adverse Reactions).
Severe injuries: Due to its pharmacological properties, zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries.
Effects on ability to drive and use machines: Zolpidem Sandoz has major influence on the ability to drive and use machines.
Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision and reduced alertness and impaired driving the morning after therapy (see Adverse Reactions).

In order to minimize this risk a resting period of at least 8 hours is recommended between taking Zolpidem Sandoz and driving, using machinery and working at heights. It is recommended not to drive or perform activities that require mental alertness until 8 hours after taking zolpidem.

Driving ability impairment and behaviors such as ‘sleep-driving’ have occurred with Zolpidem Sandoz alone at therapeutic doses.
Furthermore, the co-administration of ZOLPIDEM SANDOZwith alcohol and other CNS depressants increases the risk of such behaviors (see Interactions). Patients should be warned not to use alcohol or other psychoactive substances when taking ZOLPIDEM SANDOZ.

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Use In Pregnancy & Lactation

Pregnancy: For ZOLPIDEM SANDOZ, no or very limited amount of data on pregnant patients are available. Although animal studies have shown no teratogenic or embryotoxic effects, safety in pregnancy has not been established. As with all drugs ZOLPIDEM SANDOZ should be avoided in pregnancy particularly during the first trimester.
If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician about stopping the product if she intends to become or suspects that she is pregnant.
If, for compelling medical reasons, ZOLPIDEM SANDOZ is administered during the late phase of pregnancy, or during labour, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected due to the pharmacological action of the product.

Cases of severe neonatal respiratory depression have been reported when ZOLPIDEM SANDOZ was used with other CNS depressants at the end of pregnancy.
Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
Lactation: Small quantities of ZOLPIDEM SANDOZ appear in breast milk. The use of ZOLPIDEM SANDOZ in nursing mothers is therefore not recommended.

Adverse Reactions

The following CIOMS frequency rating is used, when applicable: Very common more than 10%; Common more than 1 and less 10%; Uncommon more than 0.1 and <1%; Rare more than0.01 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 SANDOZ use, particularly for certain CNS and gastrointestinal events. As recommended in Dosage & Administration, they should in theory be less if ZOLPIDEM SANDOZ 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 behavior, somnambulism (see Precautions), dependence (withdrawal symptoms, or rebound effects may occur after treatment discontinuation), libido disorder, depression (see Precautions), euphoric mood.
Most of these psychiatric undesirable effects are related to paradoxical reactions.
Nervous system disorders: Common: somnolence, headache, dizziness, exacerbated insomnia, cognitive disorders such as anterograde amnesia: (amnestic effects may be associated with inappropriate behavior).
Uncommon: paranesthesia, tremor.
Not known: depressed level of consciousness, disturbance in attention, speech disorder.
Eye disorders: Uncommon: diplopia, vision blurred.
Very rare: visual impairment.
Respiratory, thoracic and mediastinal disorders: Not Known: respiratory depression (see Precautions).
Gastro-intestinal disorders: Common: diarrhea, nausea, vomiting, abdominal pain.
Hepatobiliary disorders: Not known: liver enzymes elevated, hepatocellular, cholestatic or mixed liver injury (see Dosage & Administration, Contraindications and Precautions).
Metabolism and nutrition disorders: Uncommon: appetite disorder.
Skin and subcutaneous tissue disorders: Not known: rash, pruritus, urticaria, hyperhidrosis.
Musculoskeletal and connective tissue disorders: Common: back pain.
Uncommon: myalgia, muscle spasms.
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) (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

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Drug Interactions

Not recommended: Concomitant intake with alcohol: 

The sedative effect may be enhanced when the product is used in combination with alcohol. This affects the ability to drive or use machines.
Zolpidem should not be taken together with alcohol, other medicines that have an effect on mental function and/or the central nervous system.
Take into account: Combination with CNS depressants:

Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anesthetics and sedative antihistamines.

Therefore, concomitant use of Zolpidem Sandoz with these drugs may increase drowsiness and next-day psychomotor impairment, including impaired driving ability (see Precautions and Effects on ability to drive and use machines under Precautions).

Also, isolated cases of visual hallucinations were reported in patients taking Zolpidem Sandoz with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine.
Co-administration of fluvoxamine may increase blood levels of Zolpidem Sandoz, concurrent use is not recommended.
In the case of narcotic analgesics enhancement of euphoria may also occur leading to an increase in psychological dependence.
CYP450 Inhibitors and inducers: Co-administration of ciprofloxacin may increase blood levels of Zolpidem Sandoz, concurrent use is not recommended.
Compounds, which inhibit certain hepatic enzymes (particularly cytochrome P450), may enhance the activity of benzodiazepines and benzodiazepine-like agents.
Zolpidem Sandoz is metabolized via several hepatic cytochrome P450 enzymes, the main enzyme being CYP3A4 with the contribution of CYP1A2.

The pharmacodynamics effect of Zolpidem Sandoz is decreased when it is administered with a CYP3A4 inducer such as rifampicin and St. John’s Wort. St. John’s Wort has been shown to have a pharmacokinetic interaction with zolpidem.

Co-administration of St. John’s Wort may decrease blood levels of zolpidem, concurrent use is not recommended.
However when Zolpidem Sandoz was administered with itraconazole (a CYP3A4 inhibitor) its pharmacokinetics and pharmacodynamics were not significantly modified. The clinical relevance of these results is unknown.

Co-administration of ZOLPIDEM SANDOZ with ketoconazole (200mg twice daily), a potent CYP3A4 inhibitor, prolonged ZOLPIDEM SANDOZelimination half-life, increased total AUC, and decreased apparent oral clearance when compared to ZOLPIDEM SANDOZ plus placebo.

The total AUC for ZOLPIDEM SANDOZ, when co-administered with ketoconazole, increased by a factor of 1.83 when compared to ZOLPIDEM SANDOZ alone.

A routine dosage adjustment of ZOLPIDEM SANDOZ is not considered necessary, but patients, should be advised that use of ZOLPIDEM SANDOZ with ketoconazole may enhance the sedative effects.
Since CYP3A4 plays an important role in ZOLPIDEM SANDOZ metabolism, possible interactions with drugs that are substrates or inducers of CYP3A4 should be considered.