Medication info
Stillex Tablet 10mg (Zolpidem Tartrate)

Stillex Tablet 10mg (Zolpidem Tartrate)

Prescription medicationTabletOral
Ingredient · strength
Zolpidem Tartrate›10mg / 1 tablet
Manufacturer / importer
Myungmoon Pharmaceutical Co., Ltd.
Appearance
White, rectangular, film-coated tablet
Packaging
28 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201406022 · Approved 2014.12.23 · Insurance code 649806810

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. The lowest effective dose should be used, and the recommended dose of 10mg should not be exceeded. Because elderly or debilitated patients may be sensitive to the effects of this medicine, the recommended dose is 5mg, and the daily dose should not exceed 10mg. Since metabolism and excretion of this medicine may be reduced in patients with hepatic impairment, 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 this medicine may impair driving or other activities requiring full alertness the following day, take it once immediately before bedtime, allowing at least 7-8 hours between taking the medicine and waking up. The duration of treatment usually varies from a few days to 2 weeks, and up to a maximum of 4 weeks; the dose should be tapered gradually when clinically appropriate. As with other hypnotics, long-term use is not recommended. Treatment should be as brief as possible and should not exceed 4 weeks. Since the risk of abuse and dependence increases with the duration of treatment, do not administer it beyond the maximum treatment period without reassessing the patient's condition.
Child dose
Do not administer this medicine to children.

Ingredients

Manufacturer
Myungmoon Pharmaceutical Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia in adults

  • Insomnia
View approved original text

This medication is used to improve insomnia in adults, specifically the difficulty in falling asleep or maintaining sleep, over a short period. It helps enhance the quality of sleep and restore normal sleep patterns for individuals whose daily life is affected by insomnia.

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. The lowest effective dose should be used, and the recommended dose of 10mg should not be exceeded. Because elderly or debilitated patients may be sensitive to the effects of this medicine, the recommended dose is 5mg, and the daily dose should not exceed 10mg. Since metabolism and excretion of this medicine may be reduced in patients with hepatic impairment, 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 this medicine may impair driving or other activities requiring full alertness the following day, take it once immediately before bedtime, allowing at least 7-8 hours between taking the medicine and waking up. The duration of treatment usually varies from a few days to 2 weeks, and up to a maximum of 4 weeks; the dose should be tapered gradually when clinically appropriate. As with other hypnotics, long-term use is not recommended. Treatment should be as brief as possible and should not exceed 4 weeks. Since the risk of abuse and dependence increases with the duration of treatment, do not administer it 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 such as walking or driving during sleep after initial use or re-dosing. These behaviors can result in serious injury to the patient or those around them, hence caution is needed. Sleep disturbances can signal physical or mental issues, so accurate assessment of the underlying cause should be conducted before using this medication. If symptoms do not improve after 7-10 days of use, consultation with a healthcare professional is recommended as other conditions may exist. This drug may cause dose-dependent side effects, especially in older patients, so it is important to start with the lowest effective dose. Unusual behaviors such as aggression, hallucinations, or anxiety may occur, and any abnormal symptoms should be reported to a healthcare professional immediately. Cognitive impairment and psychiatric symptoms may also unexpectedly arise, so careful observation is required. This drug has a central nervous system depressant effect, which may cause cognitive impairment and should be avoided when driving or operating machinery. Taking this medication with alcohol or other central nervous system depressants can enhance its effects, potentially leading to dangerous situations, so they should never be taken together. Combined use with opioid analgesics can lead to respiratory depression or coma, and should only be used at the minimum necessary dose with close monitoring of the patient. This medication should not be used in patients with severely impaired liver function, and use should be discontinued immediately if allergic reactions or severe side effects occur. Women who are pregnant or breastfeeding should ideally avoid using this medication, with increased caution particularly during early pregnancy. This medication is not recommended for children or adolescents under 18 years of age due to a lack of established safety and efficacy. This medication may cause dependence and tolerance, so long-term use is not advised, and when discontinuing, it should be tapered gradually. After taking this medication, ensure sufficient sleep time to avoid memory loss or unusual behaviors, and consult a healthcare professional immediately if abnormal symptoms occur. In case of overdose, severe symptoms such as reduced consciousness and respiratory depression may occur, necessitating immediate emergency treatment.

Side effects

  • Sleepwalking
  • sleep driving
  • complex sleep behaviors
  • drowsiness
  • headache
  • dizziness
  • worsening insomnia
  • antegrade amnesia
  • paresthesia
  • tremors
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  • attention deficits
  • language disturbances
  • decreased consciousness
  • hallucinations
  • anxiety
  • nightmares
  • depression
  • confusion
  • irritability
  • restlessness
  • aggression
  • somnambulism
  • relief
  • sexual dysfunction
  • delusions
  • dependency
  • anger
  • abnormal behavior
  • fatigue
  • gait disturbances
  • falls
  • drug tolerance
  • diplopia
  • visual blurring
  • visual impairment
  • respiratory depression
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • lower back pain
  • joint pain
  • myalgia
  • muscle cramps
  • cervical pain
  • muscle weakness
  • rash
  • itching
  • hyperhidrosis
  • urticaria
  • angioneurotic edema
  • elevated liver enzymes
  • hepatocellular damage
  • cholestatic liver injury
  • upper respiratory infection
  • lower respiratory infection
  • abnormal appetite
  • headache
  • dizziness
  • hallucinations
  • fainting
  • confusion
  • impaired consciousness
  • drowsiness
  • coma
  • cardiovascular system weakening
  • respiratory system weakening

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 from air and moisture. It is best to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White, rectangular, film-coated tablet

Package unit

28 tablets/bottle, 300 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.