Medication info
Zolpidem Tablets (Zolpidem Tartrate)

Zolpidem Tablets (Zolpidem Tartrate)

Prescription medicationTabletOral
Ingredient · strength
Zolpidem Tartrate›10mg / 1 tablet
Manufacturer / importer
Korea Pharmaceutical Co., Ltd.
Appearance
White rectangular film-coated tablets
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200606262 · Approved 2006.06.20 · Insurance code 642801200

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, administer 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. Elderly or debilitated patients may be more sensitive to the effects of this medicine; the recommended dose is 5mg, and the daily dose must not exceed 10mg. Since hepatic impairment may reduce the metabolism and excretion of this medicine, 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 medication adherence is good but the clinical response is inadequate. Since taking this medicine may impair driving or other activities that require full alertness the next day, take it once immediately before bedtime and allow at least 7-8 hours between taking the medicine and waking up. The duration of treatment generally ranges from a few days to 2 weeks, and up to a maximum of 4 weeks. Reduce the dose gradually when clinically appropriate. As with other hypnotics, long-term use is not recommended. The duration of 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 continue treatment beyond the maximum duration without reassessing the patient's condition.
Child dose
Do not administer this medicine to children.

Ingredients

Manufacturer
Korea Pharmaceutical 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 insomnia in adults. It helps alleviate difficulties in falling asleep or frequent awakenings due to insomnia, thereby aiding restful sleep. This, in turn, supports the improvement of sleep quality and reduction of fatigue in daily life.

How to take

Adult dose

Because this medicine has a rapid onset of action, administer 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. Elderly or debilitated patients may be more sensitive to the effects of this medicine; the recommended dose is 5mg, and the daily dose must not exceed 10mg. Since hepatic impairment may reduce the metabolism and excretion of this medicine, 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 medication adherence is good but the clinical response is inadequate. Since taking this medicine may impair driving or other activities that require full alertness the next day, take it once immediately before bedtime and allow at least 7-8 hours between taking the medicine and waking up. The duration of treatment generally ranges from a few days to 2 weeks, and up to a maximum of 4 weeks. Reduce the dose gradually when clinically appropriate. As with other hypnotics, long-term use is not recommended. The duration of 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 continue treatment beyond the maximum duration without reassessing the patient's condition.

Child dose

Do not administer this medicine to children.

Precautions

This medication may cause complex behaviors while asleep, such as walking or driving, when taken initially or when restarting treatment. Caution is advised as there is a risk of injury to oneself or others during such activities. When experiencing sleep disturbances, it is essential to seek a doctor's evaluation to begin treatment, as there may be underlying physical or mental issues. Older individuals should use the lowest effective dose of this medication to ensure safety. Adverse effects may occasionally include aggressive or strange behaviors, hallucinations, and confusion, which should be reported immediately. There may also be symptoms of memory lapses or worsening depression, necessitating caution. This medication is not to be taken with alcohol or other sedatives, as this can enhance effects and pose dangers. In particular, combining it with opioid analgesics can lead to respiratory suppression, which may be life-threatening, thus consultation with a physician is required. Patients with severe liver or respiratory illnesses, individuals under 18 years of age, and those with psychiatric disorders should generally avoid this medication. If severe allergic reactions or breathing difficulties occur while taking this medication, emergency treatment should be sought immediately. This medication should be taken just before bedtime, and dangerous activities such as driving or operating machinery must be avoided for 7-8 hours after dosing. Pregnant or breastfeeding women are advised to avoid this medication, and those planning to conceive should discuss it with their doctor. As long-term use may lead to dependence, it is crucial to adhere strictly to the dosage and duration as directed by a physician. Drowsiness or dizziness may occur after taking this medication, so caution is necessitated to avoid falling or injury. If the medication is suddenly discontinued, withdrawal symptoms may manifest, necessitating a gradual reduction according to the doctor's instructions. If insomnia does not improve while using this medication, a reevaluation of other underlying causes is required. Special caution is necessary for this medication in children, elderly patients, and those with impaired liver or kidney function, and dosage adjustments may be necessary. There may be drug interactions, so notify your doctor or pharmacist if you are taking other medications.

Side effects

  • sleepwalking
  • sleep driving
  • complex sleep behavior
  • injury
  • fatal injury
  • abnormal aggression
  • extroversion
  • bizarre behavior
  • anxiety
  • hallucinations
Show 98 more
  • depersonalization
  • amnesia
  • suicidal behavior
  • exacerbation of depression
  • headache
  • dizziness
  • exacerbation of insomnia
  • antegrade amnesia
  • sensory abnormalities
  • tremors
  • attention deficits
  • speech disorders
  • decreased level of consciousness
  • hallucinations
  • anxiety
  • nightmares
  • depression
  • confusion
  • irritability
  • restlessness
  • aggression
  • somnambulism
  • euphoria
  • sexual dysfunction
  • delusions
  • dependency
  • anger
  • abnormal behavior
  • fatigue
  • gait disturbance
  • falls
  • drug tolerance
  • diplopia
  • visual haze
  • visual impairment
  • respiratory depression
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • back pain
  • joint pain
  • muscle pain
  • muscle cramps
  • neck pain
  • muscle weakness
  • rash
  • itching
  • hyperhidrosis
  • urticaria
  • angioedema
  • elevated liver enzymes
  • liver damage
  • upper respiratory infection
  • lower respiratory infection
  • altered appetite
  • withdrawal symptoms
  • headache
  • muscle pain
  • extreme anxiety
  • tension
  • anxiety
  • confusion
  • excitability
  • unreality
  • depersonalization
  • auditory hypersensitivity
  • limb paresthesia and numbness
  • light sensitivity
  • noise sensitivity
  • hypersensitivity to physical contact
  • hallucinations
  • epileptic seizures
  • mood disturbances
  • anxiety
  • anxiety
  • anxiety
  • exacerbation of insomnia
  • agitation
  • excitability
  • aggression
  • delusions
  • rage
  • nightmares
  • hallucinations
  • abnormal behavior
  • somnambulism
  • psychomotor retardation
  • drowsiness
  • decreased level of consciousness
  • falls
  • severe injury
  • drowsiness
  • prolonged reaction time
  • dizziness
  • blurred vision
  • decreased attention
  • impaired driving ability

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White rectangular film-coated tablets

Package unit

28 tablets/bottle, 100 tablets/bottle

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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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.