Medication info
Zolpidem Tartrate 5 mg Tablets

Zolpidem Tartrate 5 mg Tablets

Prescription medicationTabletOral
Ingredient · strength
Zolpidem Tartrate›5mg / 1 tablet
Manufacturer / importer
Myungin Pharmaceutical Co., Ltd.
Appearance
Pink rectangular film-coated tablets
Packaging
28 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 201606485 · Approved 2016.11.04 · Insurance code 651904470

Summary

Main use
Short-term treatment of insomnia in adults
Who takes it
Adults · Children
Adult dose
Because this medicine takes effect rapidly, administer orally immediately before bedtime. The recommended daily dose for adults is 10mg. Use the lowest effective dose; do not exceed the recommended dose of 10mg. In elderly or debilitated patients, who may be more sensitive to the effects of this medicine, the recommended dose is 5mg; do not exceed 10mg per day. As liver impairment may reduce the metabolism and excretion of this medicine, start with a dose of 5mg, with special caution, as in elderly patients. In adults under 65 years of age, the dose may be increased to 10mg if adherence is good but the clinical response is inadequate. As taking 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 waking. The treatment period usually ranges from a few days to 2 weeks, and may be up to 4 weeks. Gradually reduce the dose when clinically appropriate. As with other sleeping pills, long-term use is not recommended. The treatment period should be as short as possible and should not exceed 4 weeks. The risk of abuse and dependence increases with the duration of treatment, so do not continue beyond the maximum treatment period without reassessing the patient's condition.
Child dose
Do not administer this medicine to children.

Ingredients

Manufacturer
Myungin Pharmaceutical Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia in adults

  • Insomnia
View approved original text

This medication is used to alleviate short-term symptoms of insomnia occurring in adults.

How to take

Adult dose

Because this medicine takes effect rapidly, administer orally immediately before bedtime. The recommended daily dose for adults is 10mg. Use the lowest effective dose; do not exceed the recommended dose of 10mg. In elderly or debilitated patients, who may be more sensitive to the effects of this medicine, the recommended dose is 5mg; do not exceed 10mg per day. As liver impairment may reduce the metabolism and excretion of this medicine, start with a dose of 5mg, with special caution, as in elderly patients. In adults under 65 years of age, the dose may be increased to 10mg if adherence is good but the clinical response is inadequate. As taking 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 waking. The treatment period usually ranges from a few days to 2 weeks, and may be up to 4 weeks. Gradually reduce the dose when clinically appropriate. As with other sleeping pills, long-term use is not recommended. The treatment period should be as short as possible and should not exceed 4 weeks. The risk of abuse and dependence increases with the duration of treatment, so do not continue 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 side effects such as sleepwalking or driving while not fully awake upon first use or after resuming use. There is a risk of serious injury or death associated with such behaviors, and immediate discontinuation of the medication is necessary if these symptoms occur. Insomnia can be a sign of physical or mental issues; therefore, if it persists for more than 7 to 10 days, an evaluation by a physician is needed to check for other disorders. Especially, elderly or frail patients are more sensitive to the side effects of this medication, and should start with the minimal dose, requiring dose adjustment and careful monitoring. This medication may trigger neurological side effects such as memory impairment, hallucinations, aggression, and anxiety; there is an increased risk of suicidal ideation in patients with depression. If any new abnormal behaviors or symptoms occur after taking this medication, immediate evaluation by a physician is required. This medication acts as a central nervous system depressant; therefore, activities such as driving or operating machinery should be avoided after use, and concurrent use with alcohol or other CNS depressants should be avoided as side effects may be exacerbated. Co-administration with opioid analgesics can lead to severe side effects such as respiratory depression or coma, so it should only be used at the lowest dose for a short time under thorough physician supervision when absolutely necessary. This medication can rarely cause anaphylactic reactions that result in swelling of the tongue or throat, requiring immediate discontinuation and emergency treatment if such symptoms occur. Patients with severely impaired liver function should not use this medication, and patients with mild liver impairment should reduce the dose and be monitored closely. This medication should not be used in children under 18 years, patients with severe respiratory failure, mental illness, or hypersensitivity. Use should be avoided particularly in the first three months of pregnancy and during late pregnancy, as well as in nursing women. Prolonged use can lead to tolerance or dependence on the medication, making it crucial to use the minimum effective dose for the shortest duration possible. Abrupt discontinuation can result in withdrawal symptoms such as headaches, anxiety, and confusion, and dosage should be tapered gradually under a physician's guidance. Taking this medication with food can delay its effect, so it is generally recommended to take it on an empty stomach just before bedtime. Lastly, while taking this medication, avoid alcohol or other CNS depressants, and exercise caution with activities requiring full attention such as driving or operating machinery.

Side effects

  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • drowsiness
  • headache
  • dizziness
  • worsening of insomnia
  • antegrade amnesia
  • sensory disturbances
  • tremors
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  • concentration difficulties
  • speech disorders
  • decreased consciousness
  • hallucinations
  • anxiety
  • nightmares
  • depression
  • confusion
  • hyperexcitability
  • restlessness
  • aggression
  • somnambulism
  • euphoria
  • sexual dysfunction
  • delusions
  • dependency
  • anger
  • abnormal behavior
  • fatigue
  • gait disorders
  • falls
  • drug tolerance
  • diplopia
  • visual clouding
  • visual impairment
  • respiratory depression
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • lower back pain
  • joint pain
  • muscle pain
  • muscle cramps
  • neck pain
  • muscle weakness
  • rash
  • itching
  • sweating
  • urticaria
  • angioedema
  • elevated liver enzymes
  • hepatic cell damage
  • cholestatic liver damage
  • upper respiratory infection
  • lower respiratory infection
  • appetite changes
  • lingual angioedema
  • glottic angioedema
  • laryngeal angioedema
  • dyspnea
  • throat obstruction
  • nausea
  • vomiting
  • altered consciousness
  • coma
  • cardiovascular weakening
  • respiratory system weakening
  • headache
  • muscle pain
  • extreme anxiety
  • tension
  • confusion
  • excitability
  • unreality
  • depersonalization
  • auditory hypersensitivity
  • limb numbness and tingling
  • light hypersensitivity
  • noise hypersensitivity
  • sensitivity to physical contact
  • hallucinations
  • interictal seizures
  • mood changes
  • anxiety
  • agitation
  • excitability
  • rage
  • reduced attention
  • impaired driving ability
  • drowsiness
  • blurred vision

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, it is safe to store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink rectangular film-coated tablets

Package unit

28 tablets/bottle, 200 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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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.