Medication info
Zolpidem Tablets 10 mg (Zolpidem Tartrate)

Zolpidem Tablets 10 mg (Zolpidem Tartrate)

Prescription medicationTabletOral
Ingredient · strength
Zolpidem Tartrate›10mg / 1 tablet
Manufacturer / importer
Han In Pharmaceutical Co., Ltd.
Appearance
White oblong film-coated tablet
Packaging
28 tablets/bottle, 30 tablets/bottle, 100 tablets/bottle, 100 tablets/box [10 tablets/PTP × 10]
Approval status
Active

MFDS item code 200512142 · Approved 2005.04.08 · Insurance code 657200670

Summary

Main use
Short-term treatment of insomnia in adults
Who takes it
Adults · Children
Adult dose
Because this drug has a rapid onset of action, take it orally immediately before bedtime. The recommended daily dose for adults is 10mg. Use the lowest effective dose, and do not exceed the recommended dose of 10mg. For elderly or debilitated patients, the recommended dose is 5mg, as they may be sensitive to the effects of this drug; do not exceed 10mg per day. Since liver impairment may reduce the metabolism and excretion of this drug, start at a dose of 5mg, with 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 insufficient. Since taking this drug may impair driving or other activities that require full alertness the following day, take it once immediately before bedtime and allow at least 7-8 hours between taking the drug and getting up. The duration of treatment varies, usually from several days to 2 weeks, and up to a maximum of 4 weeks; when clinically appropriate, the dose should be reduced gradually. As with other sleeping medications, long-term use is not recommended. The treatment period 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 beyond the maximum treatment period without reassessing the patient’s condition.
Child dose
Do not administer this medicine to children.

Ingredients

Manufacturer
Han In Pharmaceutical Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia in adults

  • Insomnia
View approved original text

This medication is used for the treatment of short-term insomnia in adults. It helps to induce sleep easily and improves issues related to difficulty falling asleep.

How to take

Adult dose

Because this drug has a rapid onset of action, take it orally immediately before bedtime. The recommended daily dose for adults is 10mg. Use the lowest effective dose, and do not exceed the recommended dose of 10mg. For elderly or debilitated patients, the recommended dose is 5mg, as they may be sensitive to the effects of this drug; do not exceed 10mg per day. Since liver impairment may reduce the metabolism and excretion of this drug, start at a dose of 5mg, with 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 insufficient. Since taking this drug may impair driving or other activities that require full alertness the following day, take it once immediately before bedtime and allow at least 7-8 hours between taking the drug and getting up. The duration of treatment varies, usually from several days to 2 weeks, and up to a maximum of 4 weeks; when clinically appropriate, the dose should be reduced gradually. As with other sleeping medications, long-term use is not recommended. The treatment period 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 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 various behaviors while you are not fully awake, such as walking or driving during sleep when you first take it or if you take it again. There is a risk of serious injury or harm to others during such behavior. Additionally, behaviors like preparing food, making phone calls, or sexual relations have also been reported, and most individuals do not remember these actions afterward. If complex sleep-related behaviors occur, the use of this medication should be discontinued immediately. Insomnia can signal physical or mental issues, so a thorough evaluation of the patient's condition should be conducted before starting treatment with this medication. If symptoms do not improve after taking the medication for 7-10 days, further evaluation may be needed for other underlying conditions. This medication's side effects can be particularly severe in the elderly, so it is important to use the minimum effective dose. During use, abnormal behaviors such as aggression, anxiety, hallucinations, and delusions can occur, which may produce effects similar to alcohol or other central nervous system depressants. Amnesia or other neuropsychiatric symptoms may unpredictably arise, and in patients with depression, the risk of suicidal behavior may increase, so caution is advised. Any new abnormal behaviors or symptoms should be reported to a healthcare provider immediately. It is recommended to gradually reduce the dosage, as abrupt cessation may lead to withdrawal symptoms or other side effects. After taking the medication, avoid dangerous activities such as driving or operating machinery, especially if taken with alcohol. Co-administration with opioid analgesics can result in severe sedation, respiratory depression, coma, and even death, so extreme caution is necessary. This medication may rarely cause swelling of the tongue, throat, or larynx, and anaphylactic reactions such as difficulty breathing, nausea, and vomiting can occur, so immediate cessation of use is required if any abnormal symptoms appear. It should not be used in patients with severe liver dysfunction, and those with mild liver function impairment should have dosage reduction and close monitoring. This medication is contraindicated in patients under 18 years, those with obstructive sleep apnea, myasthenia gravis, severe liver failure, acute respiratory failure, psychosis, or hypersensitivity to this medication. Careful administration is required in the elderly, frail patients, and those with impaired respiratory, renal, or liver function, and the recommended dosages must be strictly followed while closely monitoring their condition. Common side effects during use include drowsiness, headache, dizziness, worsening of insomnia, memory impairment, and various psychiatric symptoms such as hallucinations, anxiety, nightmares, and depression. Additionally, symptoms such as fatigue, diarrhea, nausea, vomiting, back pain, joint pain, muscle pain, muscle cramps, neck pain, weakness, rash, itching, sweating, and increased liver enzymes have been reported. If insomnia persists or worsens during the use of this medication, a reassessment for potential underlying conditions should be conducted, as it is not recommended as a first-line treatment for mental disorders. Tolerance or dependence on the medication may develop; therefore, long-term use should be avoided, and abrupt cessation may lead to withdrawal symptoms, so gradual tapering is important. After taking the medication, at least 7-8 hours of adequate sleep is necessary, and avoid alcohol or other central nervous system depressants during treatment. Co-administration with other central nervous system drugs should be approached with caution as sedative effects may increase, especially when taken with opioid analgesics, where dosage and duration should be minimized. Avoid use during pregnancy, particularly during the first trimester, and caution should be exercised during the second and third trimesters due to potential effects on the fetus and newborn. Nursing mothers are advised not to take this medication as it may be excreted in breast milk. The safety and efficacy of this medication have not been established in children, and elderly patients are at a higher risk of side effects, so dosage should be adjusted, and close monitoring is necessary. In case of overdose, symptoms can range from altered consciousness to coma, requiring immediate medical attention.

Side effects

  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • injuries
  • food preparation and eating
  • making phone calls
  • actions during sexual intercourse
  • amnesia
  • neuropsychiatric symptoms
  • suicidal behavior
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  • exacerbation of depression
  • abnormal aggression
  • extroversion
  • bizarre behavior
  • anxiety
  • hallucinations
  • derealization
  • anterograde amnesia
  • drowsiness
  • headache
  • dizziness
  • exacerbation of insomnia
  • sensory disturbances
  • tremors
  • concentration difficulties
  • speech disorders
  • lowered level of consciousness
  • hallucinations
  • anxiety
  • nightmares
  • depression
  • confusion
  • irritability
  • restlessness
  • aggression
  • parasomnia
  • relief
  • sexual desire disorder
  • delusions
  • dependence
  • anger
  • abnormal behavior
  • fatigue
  • gait disturbances
  • falls
  • drug tolerance
  • diplopia
  • visual obscurity
  • visual impairment
  • respiratory depression
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • back pain
  • joint pain
  • muscle pain
  • muscle spasms
  • neck pain
  • myasthenia
  • rash
  • itching
  • hyperhidrosis
  • urticaria
  • angioedema
  • elevated liver enzymes
  • liver damage
  • upper respiratory infection
  • lower respiratory infection
  • abnormal appetite
  • tongue angioedema
  • glottic angioedema
  • laryngeal angioedema
  • dyspnea
  • pharyngeal obstruction
  • nausea
  • vomiting
  • impaired consciousness
  • drowsiness
  • coma
  • cardiovascular weakness
  • respiratory system weakness
  • hypotension
  • central nervous system depression
  • agitation
  • withdrawal symptoms
  • headache
  • muscle pain
  • extreme anxiety
  • tension
  • anxiety
  • confusion
  • excitability
  • unreality
  • auditory hypersensitivity
  • limb tingling and numbness
  • hypersensitivity to light
  • noise
  • physical contact
  • hallucinations
  • epileptic seizures
  • rebound insomnia
  • mood disorder
  • anxiety
  • anxiety
  • psychomotor retardation
  • drowsiness
  • prolonged reaction time
  • dizziness
  • drowsiness
  • blurred vision
  • decreased attention
  • impaired driving ability
  • fainting
  • confusion

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture, and it is best to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

28 tablets/bottle, 30 tablets/bottle, 100 tablets/bottle, 100 tablets/box [10 tablets/PTP × 10]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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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.