Medication info
Stilnox Tablet 10 mg (Zolpidem Tartrate)

Stilnox Tablet 10 mg (Zolpidem Tartrate)

Prescription medicationTabletOral
Ingredient · strength
Zolpidem Tartrate›10mg / 1 tablet
Manufacturer / importer
Handok Co., Ltd.
Appearance
White, rectangular film-coated tablets
Packaging
100 tablets/bottle, 14 tablets/box [(14 tablets/blister)], 28 tablets/box [(14 tablets/blister x 2)]
Approval status
Active

MFDS item code 200700634 · Approved 2007.01.17 · Insurance code 652100640

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 going to bed. The recommended daily dose for adults is 10 mg. Use the lowest effective dose; do not exceed the recommended dose of 10 mg. Older or debilitated patients may be more sensitive to the effects of this medicine. The recommended dose for these patients is 5 mg, and the daily dose should not exceed 10 mg. Because hepatic impairment may reduce the metabolism and excretion of this medicine, start at a dose of 5 mg, with special caution as in older patients. In adults younger than 65 years, the dose may be increased to 10 mg if 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 going to bed and allow at least 7-8 hours between taking the medicine and getting up. The duration of treatment generally ranges from several days to 2 weeks, and may be up to 4 weeks. If clinically appropriate, gradually reduce the dose. As with other sleeping medicines, long-term use is not recommended. The treatment duration should be as short as possible and should not exceed 4 weeks. Because the risk of abuse and dependence increases with the duration of treatment, 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
Handok 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 improve difficulties in falling asleep or frequent awakenings, promoting restful sleep. It is effective in safely alleviating insomnia symptoms during short-term use. Therefore, it helps reduce the inconveniences in daily life caused by insomnia and allows for comfortable sleep. This drug is used for the short-term treatment of insomnia.

How to take

Adult dose

Because this medicine has a rapid onset of action, take it orally immediately before going to bed. The recommended daily dose for adults is 10 mg. Use the lowest effective dose; do not exceed the recommended dose of 10 mg. Older or debilitated patients may be more sensitive to the effects of this medicine. The recommended dose for these patients is 5 mg, and the daily dose should not exceed 10 mg. Because hepatic impairment may reduce the metabolism and excretion of this medicine, start at a dose of 5 mg, with special caution as in older patients. In adults younger than 65 years, the dose may be increased to 10 mg if 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 going to bed and allow at least 7-8 hours between taking the medicine and getting up. The duration of treatment generally ranges from several days to 2 weeks, and may be up to 4 weeks. If clinically appropriate, gradually reduce the dose. As with other sleeping medicines, long-term use is not recommended. The treatment duration should be as short as possible and should not exceed 4 weeks. Because the risk of abuse and dependence increases with the duration of treatment, 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 lead to behaviors such as walking or driving while asleep, due to lack of normal awareness when first taken or after resuming use. There is a risk of serious injury or harm to others during such behaviors, thus caution is necessary. If complex sleep behaviors occur, this medication should be discontinued immediately. Patients should be thoroughly evaluated for their physical or mental condition before starting treatment for insomnia, and if symptoms do not improve after 7 to 10 days of treatment, reevaluation is needed as there may be other underlying causes. It is especially important to adjust the dosage to a minimum for elderly patients to reduce the risk of side effects. This medication can occasionally cause abnormal behavioral changes such as aggression, hallucinations, and anxiety, and amnesia or psychiatric symptoms can unpredictably occur. Reports of suicidal ideation or worsening depression have been noted, so mental health status should be monitored closely. Abrupt discontinuation of this medication may lead to withdrawal symptoms or rebound insomnia, so it is recommended to taper off gradually. After taking the medication, activities requiring concentration, such as driving or operating machinery, should be avoided, and it should not be used in combination with alcohol or other central nervous system depressants as this may worsen side effects. Caution is needed when used in conjunction with opioid analgesics due to the risk of severe respiratory depression or coma. Allergic reactions such as swelling of the tongue, vocal cords, and larynx or breathing difficulties may occur, and if any abnormal symptoms appear, discontinue use immediately and seek emergency treatment. It should not be used in patients with severe liver disease, and the dose should be reduced and closely monitored in patients with compromised liver function. It is advisable to avoid use during pregnancy, especially in the first trimester and late stages, and it should not be used by nursing mothers. This medication has not established safety and efficacy in children under 18 years of age. This drug affects the central nervous system, so in elderly or frail patients, it should be started at a low dose and monitored closely for their condition. In case of overdose, severe symptoms such as decreased consciousness and respiratory depression may occur, necessitating immediate emergency treatment. This medication should be stored out of the reach of children and kept in its original container for safety.

Side effects

  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • drowsiness
  • headache
  • dizziness
  • worsening of insomnia
  • presenile forgetfulness
  • sensory disturbances
  • tremors
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  • concentration difficulties
  • speech disorders
  • decreased level of consciousness
  • hallucinations
  • anxiety
  • nightmares
  • depression
  • confusion
  • irritability
  • restlessness
  • aggression
  • somnambulism
  • sense of relief
  • sexual dysfunction
  • delusions
  • dependency
  • anger
  • abnormal behavior
  • delirium
  • fatigue
  • gait disturbances
  • 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
  • myasthenia
  • rash
  • itching
  • hyperhidrosis
  • urticaria
  • angioedema
  • elevated liver enzymes
  • hepatocellular damage
  • cholestatic liver damage
  • mixed liver damage
  • upper respiratory infection
  • lower respiratory infection
  • appetite changes
  • lingual angioedema
  • vocal cord angioedema
  • laryngeal angioedema
  • dyspnea
  • throat obstruction
  • nausea
  • vomiting
  • impaired consciousness
  • hypotension
  • central nervous system depression
  • headache
  • muscle pain
  • extreme anxiety
  • tension
  • agitation
  • confusion
  • excitement
  • derealization
  • depersonalization
  • auditory hypersensitivity
  • limb numbness
  • numbness
  • light hypersensitivity
  • noise hypersensitivity
  • physical contact hypersensitivity
  • hallucinations
  • delirium
  • interstitial seizures
  • mood disturbances
  • instability
  • excitability
  • rage
  • psychomotor retardation
  • impaired driving ability
  • drowsiness
  • prolonged reaction time
  • dizziness
  • blurred vision
  • decreased attention
  • impaired driving ability
  • fainting
  • confusion

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 exposure to air or moisture. It is recommended to maintain a storage temperature between 1°C and 30°C. Storing it this way will help preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White, rectangular film-coated tablets

Package unit

100 tablets/bottle, 14 tablets/box [(14 tablets/blister)], 28 tablets/box [(14 tablets/blister x 2)]

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.

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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.