Zolpidem Tartrate Tablets

Zolpidem tartrate. Chemical name: Bis[N,N-dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-]pyridin-3-yl]-acetamide](2R,3R)-2,3-dihydroxysuccinate Molecular formula: Molecular weight: (C19H21N3O2)2·C4H6O6

This product is a white scored coated tablet.

Oral administration. Dosage: 1. The general population should usually use the lowest effective dose for treatment with this product, 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. 2. Special population Elderly patients or patients with impaired liver function: The dose should be halved to 5 mg. The daily 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 mg, especially for 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.

1. Unknown immune system abnormalities: Anaphylactic shock (severe allergic reaction) and angioedema (severe facial swelling) may occur in the early stage of taking this product for the first time. 2. Psychiatric abnormalities Common: Hallucinations, excitement, nightmares Uncommon: Confusion state, irritability Unknown: Restlessness, aggressiveness, delusion, anger, abnormal behavior, sleepwalking (taking this product may cause sleep syndrome behavior, including sleepwalking while driving, sleepwalking while cooking and eating, and other potentially dangerous behaviors.), dependence (withdrawal symptoms or rebound reactions may occur after stopping treatment), abnormal sexual desire Most of these adverse mental reactions are related to abnormal reactions. 3. Nervous system abnormalities Common: Drowsiness, headache, dizziness, aggravated insomnia, anterograde amnesia (amnesia reactions may cause inappropriate behavior). Unknown: decreased level of consciousness. 4

This drug is contraindicated in the following cases: 1. Allergic to zolpidem or any of its ingredients. 2. Severe respiratory insufficiency. 3. Sleep apnea syndrome. 4. Severe acute or chronic liver insufficiency (risk of hepatic encephalopathy).

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 for zolpidem compared with placebo, including dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations (7.4% vs. 0%). 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 in reproductive toxicity. If the drug is prescribed to women of childbearing age, the patient should be warned to contact the physician to discuss discontinuation of the drug when she plans or suspects pregnancy. If zolpidem is used in late pregnancy or during delivery, effects on the newborn, such as hypothermia, hypotonia, and moderate respiratory depression, are expected based on the pharmacological effects of the product. Severe cases of neonatal respiratory depression have been reported when zolpidem was used concurrently with other CNS depressants in late pregnancy. In addition, infants born to mothers who used sedatives/hypnotics for a long time in late pregnancy may have serious adverse reactions.

drugInteractions

Keep sealed.

10mg*6s

24 months

Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

• Founded in:

  1998-05-26

• Address:

  No. 1, Jinlong East Road, Hetang District, Zhuzhou City, Hunan Province

• Tax NO.:

  9143020071210238X7

• Registered Funds:

  48 million yuan

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