Medication info
Sandoz Zolpidem Tablet 10 mg (Zolpidem Tartrate)

Sandoz Zolpidem Tablet 10 mg (Zolpidem Tartrate)

Prescription medicationTabletOral
Ingredient · strength
Zolpidem Tartrate›10mg / 1 tablet
Manufacturer / importer
Samil Pharm. Co., Ltd.
Appearance
White, capsule-shaped tablet with a bisect on one side and convex on both sides.
Packaging
100 tablets (10 tablets/PTP x 10)
Approval status
Active

MFDS item code 200704597 · Approved 2007.04.19 · Insurance code 643903920

Summary

Main use
Short-term treatment of insomnia in adults
Who takes it
Adults · Children
Adult dose
Because this medicine has a rapid onset of action, take it orally immediately before bedtime. The recommended adult dose is 10mg once daily. Use the lowest effective dose; do not exceed the recommended dose of 10mg. Elderly or debilitated patients may be more sensitive to the effects of this medicine. The recommended dose for these patients is 5mg, and the dose should not exceed 10mg once daily. Because hepatic impairment may reduce the metabolism and excretion of this medicine, start with a dose of 5mg and exercise special caution, as in elderly patients. For adults under 65 years of age, the dose may be increased to 10mg if adherence is good but the clinical response is inadequate. This medicine may impair driving or other activities requiring full alertness the following day. Take it once immediately before bedtime and allow at least 7-8 hours between taking the medicine and getting up. The duration of treatment usually ranges from several days to 2 weeks, and may be up to 4 weeks at most. When clinically appropriate, reduce the dose gradually. As with other sleeping medicines, long-term use is not recommended. Treatment should be as short as possible and should not exceed 4 weeks. Since the risk of abuse and dependence increases with the duration of treatment, do not administer this medicine beyond the maximum treatment period without reassessing the patient's condition.
Child dose
Do not administer this medicine to children.

Ingredients

Importer
Samil Pharm. Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia in adults

  • Insomnia
View approved original text

This medication is used for the short-term treatment of transient insomnia in adults.

How to take

Adult dose

Because this medicine has a rapid onset of action, take it orally immediately before bedtime. The recommended adult dose is 10mg once daily. Use the lowest effective dose; do not exceed the recommended dose of 10mg. Elderly or debilitated patients may be more sensitive to the effects of this medicine. The recommended dose for these patients is 5mg, and the dose should not exceed 10mg once daily. Because hepatic impairment may reduce the metabolism and excretion of this medicine, start with a dose of 5mg and exercise special caution, as in elderly patients. For adults under 65 years of age, the dose may be increased to 10mg if adherence is good but the clinical response is inadequate. This medicine may impair driving or other activities requiring full alertness the following day. Take it once immediately before bedtime and allow at least 7-8 hours between taking the medicine and getting up. The duration of treatment usually ranges from several days to 2 weeks, and may be up to 4 weeks at most. When clinically appropriate, reduce the dose gradually. As with other sleeping medicines, long-term use is not recommended. Treatment should be as short as possible and should not exceed 4 weeks. Since the risk of abuse and dependence increases with the duration of treatment, do not administer this medicine beyond the maximum treatment period without reassessing the patient's condition.

Child dose

Do not administer this medicine to children.

Precautions

This medication may cause complex behaviors while not fully awake, such as sleepwalking or driving, when taken for the first time or after a period of abstinence. Such behaviors can result in serious injury to oneself or others, so caution is advised. Taking this medication with alcohol or other central nervous system depressants can increase these risks. If complex sleep behaviors occur, discontinue the drug immediately. Insomnia may be a symptom of physical or mental health problems, so it is important to evaluate the underlying causes before treatment. If symptoms do not improve after 7-10 days of treatment, other underlying conditions should be evaluated. Elderly patients may be more sensitive to the side effects of this medication, so starting with the minimum dosage is recommended. Be cautious as abnormal changes in behavior, such as aggression, hallucinations, or confusion may occur while taking this medication. Amnesia or mental symptoms may also appear unexpectedly. There may be an increased risk of suicidal thoughts in patients with depression, requiring special observation. If new abnormal behaviors or symptoms occur during treatment, consult a healthcare professional immediately. This medication acts quickly; therefore, it should be taken just before bedtime, and attention levels may decrease afterward, making it advisable to avoid engaging in hazardous activities such as driving or operating machinery. Avoid taking it with alcohol as it can enhance the sedative effect, which poses risks. Taking it with opioid analgesics can lead to severe sedation, respiratory depression, or even death, so extreme caution is essential. This medication can rarely cause severe allergic reactions like swelling of the tongue or larynx, so discontinue use immediately if any unusual symptoms arise. It should not be used in patients with severely impaired liver function. It is contraindicated in children under 18 years old, patients with obstructive sleep apnea, severe myasthenia gravis, severe liver failure, or acute respiratory failure. Elderly or frail patients should have their dosage adjusted and monitor for side effects carefully. Possible side effects during treatment include drowsiness, dizziness, headache, worsening of insomnia, anterograde amnesia, sensory disturbance, tremors, concentration difficulties, speech disorders, hallucinations, agitation, nightmares, depression, confusion, irritability, restlessness, aggression, somnambulism, euphoria, sexual dysfunction, delusions, dependence, anger, abnormal behavior, fatigue, gait disturbance, falls, drug tolerance, diplopia, visual impairment, diarrhea, nausea, vomiting, abdominal pain, back pain, joint pain, muscle pain, and muscle cramps. Before taking it, accurately identify the cause of insomnia and check for any other conditions that may require treatment. Long-term use may lead to tolerance and dependence, so do not exceed the recommended duration. Discontinuing abruptly can lead to withdrawal symptoms; dosage should be reduced gradually according to medical advice. Use with other central nervous system depressants may enhance the effect, requiring caution. It is preferably avoided during pregnancy, especially in the first trimester, and should not be taken while breastfeeding. Safety for children has not been established; therefore, it is not for use in those under 18. In cases of drug overdose, decreased consciousness and respiratory depression may occur, requiring immediate emergency treatment. Keep this medication out of the reach of children and store it in its original container.

Side effects

  • Sleepwalking
  • sleep driving
  • complex sleep behaviors
  • drowsiness
  • headache
  • dizziness
  • worsening of insomnia
  • antegrade amnesia
  • sensory abnormalities
  • tremors
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  • concentration difficulties
  • language impairment
  • decreased level of consciousness
  • hallucinations
  • restlessness
  • nightmares
  • depression
  • confusion
  • irritability
  • agitation
  • aggression
  • somnambulism
  • euphoria
  • sexual dysfunction
  • delusions
  • dependence
  • anger
  • abnormal behavior
  • fatigue
  • gait disturbance
  • falls
  • drug tolerance
  • diplopia
  • visual blurring
  • visual impairment
  • respiratory depression
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • lower back pain
  • joint pain
  • muscle pain
  • muscle cramps
  • neck pain
  • myasthenia
  • rash
  • itching
  • hyperhidrosis
  • urticaria
  • vasculoneurotic edema
  • elevated liver enzymes
  • hepatocellular
  • cholestatic
  • or mixed liver injury
  • upper respiratory infection
  • lower respiratory infection
  • appetite changes
  • lingual angioedema
  • laryngeal angioedema
  • pharyngeal angioedema
  • respiratory distress
  • throat obstruction
  • nausea
  • vomiting
  • cognitive impairment
  • drowsiness
  • coma
  • cardiovascular weakness
  • respiratory system weakness
  • hypotension
  • central nervous system depression
  • headache
  • muscle pain
  • extreme anxiety
  • tension
  • restlessness
  • confusion
  • agitation
  • derealization
  • depersonalization
  • auditory hypersensitivity
  • tingling and numbness in limbs
  • light sensitivity
  • noise sensitivity
  • hypersensitivity to physical contact
  • hallucinations
  • interstitial seizures
  • mood changes
  • anxiety
  • restlessness
  • restlessness
  • worsening of insomnia
  • agitation
  • excitability
  • aggression
  • rage
  • nightmares
  • abnormal behavior
  • somnambulism
  • drowsiness
  • prolonged reaction time
  • dizziness
  • blurred vision
  • decreased attention
  • impaired driving ability
  • falls
  • severe injury

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature is recommended to be maintained at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White, capsule-shaped tablet with a bisect on one side and convex on both sides.

Package unit

100 tablets (10 tablets/PTP x 10)

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.