Zolpidem Tartrate Tablets

Zolpidem tartrate. Molecular weight: (C19H21N3O2)2·C4H6O6

This product is a white scored coated tablet.

Oral administration 1. Dosage The general population should usually use the lowest effective dose when using this product for treatment, and should not exceed the maximum therapeutic dose. Common dose for adults: 10 mg/tablet/day. This product should be taken before going to bed or after going to bed. Special population Elderly patients or patients with liver dysfunction: The dose should be halved to 5 mg. Each dose should not exceed 10 mg. Children Due to the lack of corresponding clinical research data, this product should not be used in patients under 18 years of age. Impaired liver function Because the clearance and metabolism of zolpidem are reduced in patients with liver damage, these patients should start with a dose of 5 ml, especially elderly patients. In adults (under 65 years old), the dose can be increased to 10 mg only when the clinical efficacy is insufficient and the drug is well tolerated. 2. Duration of treatment

The following CIOMS (Council for International Medical Organizations) frequency classification is appropriately used: Very common ≥10%; Common ≥1% and <10%; Uncommon ≥0.1% and <1%; Rare ≥0.01% and <0.1%; Very rare <0.01%; Unknown: Cannot be assessed based on available data. There is evidence that adverse reactions are dose-related to the zolpidem used, especially for certain CNS (central nervous system) events. In theory, taking zolpidem immediately before bedtime or at bedtime can reduce such events. Such events are most common in elderly patients. The occurrence of these adverse effects depends on the dose of the drug and the sensitivity of the individual patient. 1. Unknown immune system abnormalities: Allergic shock (severe

This product should not be used in the following situations: 1. Allergy to zolpidem or any of the ingredients of this product, 2. Severe respiratory insufficiency, 3. Sleep apnea syndrome, 4. Severe, acute or chronic liver insufficiency (with risk of hepatic encephalopathy), 5. Muscle weakness.

Precautions for children: The safety and efficacy of zolpidem have not been established in patients under 18 years of age. In an 8-week study in children (6-17 years old) with insomnia and attention deficit/hyperactivity disorder (ADHD), psychosis and neurological abnormalities were the most common treatment-related adverse events compared with placebo, including dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations (7.4% vs. 0%). (See [Dosage and Administration]). Precautions for pregnancy and lactation: 1. Pregnancy As a precautionary measure, it is best to avoid the use of zolpidem during pregnancy. There is essentially no or very limited data on the use of zolpidem in pregnant patients. Animal studies have not shown direct or indirect adverse effects on reproductive toxicity. If the drug is prescribed to women of childbearing age, the patient should be warned to contact her physician to discuss discontinuation of the drug if she plans or suspects pregnancy. If zolpidem is used in late pregnancy or during delivery, it is expected that the newborn may have effects, such as hypothermia, hypotonia, and moderate respiratory depression, based on the pharmacology of the product. [u] Severe cases of neonatal respiratory depression have been reported with the concurrent use of zolpidem with other CNS depressants in late pregnancy. [/u] In addition, mothers who have used sedatives/hypnotics for a long time in late pregnancy. Elderly precautions: Elderly patients should take with caution, refer to [Usage and Dosage]), [Precautions] or follow the doctor's advice. The dose for elderly patients should be halved to 5 mg.

1. Alcohol: It is not recommended to take alcohol at the same time. Concomitant use of the drug with alcohol may enhance sedation. This may affect the ability to drive or operate machinery. 2. CNS depressants: An increase in central nervous system depressant effects may occur when antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptics, anesthetics, and sedating antihistamines are used in combination. However, no clinically significant pharmacokinetic or pharmacodynamic interactions have been observed if SSRI antidepressants (fluoxetine and sertraline) are used. Enhanced euphoria may also occur when narcotic sedatives are used, leading to increased psychological dependence. 3. CYP450 inhibitors [u] and inducers: Compounds that inhibit cytochrome P450 may enhance the effects of tranquilizers like zolpidem.

Keep sealed.

10mg*10s

24 months

Lunan BETTER Pharmaceutical Co., Ltd.

• Founded in:

  2003-12-16

• Address:

  No. 209, Hongqi Road, Linyi City

• Tax NO.:

  91371300756399007K

• Registered Funds:

  115 million yuan

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