Medication info
Sleepless Tablets 10 mg (Zolpidem Tartrate)

Sleepless Tablets 10 mg (Zolpidem Tartrate)

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

MFDS item code 201701569 · Approved 2017.03.31 · Insurance code 649507420

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, 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. Older or debilitated patients may be sensitive to the effects of this drug; therefore, the recommended dose is 5mg, and the daily dose should not exceed 10mg. Because hepatic impairment may reduce the metabolism and excretion of this drug, start with a dose of 5mg, with particular caution as in older patients. In adults under 65 years of age, the dose may be increased to 10mg if medication adherence is good but the clinical response is inadequate. Because taking this drug 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 drug and waking up. The duration of treatment generally ranges from several days to 2 weeks, up to a maximum of 4 weeks. The dose should be gradually reduced when clinically appropriate. As with other hypnotics, 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 exceed the maximum treatment period without reassessing the patient's condition.
Child dose
Do not administer this drug to children.

Ingredients

Manufacturer
Unimed 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 occurring in adults.

How to take

Adult dose

Because this drug 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. Older or debilitated patients may be sensitive to the effects of this drug; therefore, the recommended dose is 5mg, and the daily dose should not exceed 10mg. Because hepatic impairment may reduce the metabolism and excretion of this drug, start with a dose of 5mg, with particular caution as in older patients. In adults under 65 years of age, the dose may be increased to 10mg if medication adherence is good but the clinical response is inadequate. Because taking this drug 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 drug and waking up. The duration of treatment generally ranges from several days to 2 weeks, up to a maximum of 4 weeks. The dose should be gradually reduced when clinically appropriate. As with other hypnotics, 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 exceed the maximum treatment period without reassessing the patient's condition.

Child dose

Do not administer this drug to children.

Precautions

This medication may cause behaviors such as sleepwalking or driving while not fully awake when taken for the first time or after a break in use. Such behaviors could lead to serious injuries or harm to others, so caution is necessary. If you experience such behaviors while taking this medication, discontinue use immediately. Insomnia can be a sign of physical or mental problems, so if symptoms persist for more than 7-10 days, consult a specialist. It is particularly important for the elderly to start with the minimum dose, which may need adjusting. This medication can sometimes cause abnormal behaviors, aggression, hallucinations, agitation, and other mental changes, so caution is advised. Signs of memory impairment, mental health issues, or suicidal thoughts may arise; if you notice any unusual symptoms, consult your doctor immediately. Discontinuing this medication suddenly may lead to withdrawal symptoms such as anxiety, headache, and confusion; hence, it should be tapered off gradually according to medical advice. After taking the medication, mental haziness may occur, so avoid dangerous activities such as driving or operating machinery. Taking this medication with alcohol may enhance its effects and pose risks, so it should never be taken together. Additionally, caution is needed when used in conjunction with other central nervous system depressants or opioid pain relievers due to the risk of severe sedation or respiratory depression. This medication should not be used or used cautiously in patients with impaired liver or kidney function, those with pulmonary disorders, mental illness, and children under 18 years of age. Women who are pregnant or breastfeeding should consult their doctor before using this medication, especially in the early and late stages of pregnancy, as it is advisable to avoid intake. Possible adverse reactions include drowsiness, dizziness, headaches, digestive disorders, and muscle pain; any severe symptoms should be reported to a doctor. This medication carries a risk of dependency, so it should not be used for long periods, and the recommended dose and duration should be strictly followed. Finally, this medication should be kept out of reach of children and stored in its original container to prevent misuse.

Side effects

  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • drowsiness
  • headache
  • dizziness
  • exacerbation of insomnia
  • predementia
  • sensory disturbances
  • tremors
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  • concentration disorders
  • speech disorders
  • decreased level of consciousness
  • hallucinations
  • agitation
  • nightmares
  • depression
  • confusion
  • hyperactivity
  • restlessness
  • aggression
  • somnambulism
  • euphoria
  • sexual dysfunction
  • delusions
  • dependence
  • anger
  • abnormal behavior
  • fatigue
  • gait disturbances
  • falls
  • drug tolerance
  • diplopia
  • visual disturbances
  • visual impairment
  • respiratory depression
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • low back pain
  • arthralgia
  • myalgia
  • muscle cramps
  • neck pain
  • muscle weakness
  • rash
  • itching
  • hyperhidrosis
  • urticaria
  • angioedema
  • elevated liver enzymes
  • liver cell damage
  • cholestatic liver injury
  • upper respiratory infections
  • lower respiratory infections
  • abnormal appetite
  • tongue angioedema
  • laryngeal angioedema
  • vocal cord angioedema
  • dyspnea
  • throat obstruction
  • nausea
  • vomiting
  • consciousness impairment
  • drowsiness
  • coma
  • cardiovascular system weakening
  • respiratory system weakening
  • hypotension
  • central nervous system suppression
  • headache
  • myalgia
  • extreme anxiety
  • tension
  • agitation
  • confusion
  • excitement
  • unreality
  • depersonalization
  • auditory hypersensitivity
  • limb paresthesia
  • numbness
  • light sensitivity
  • noise sensitivity
  • sensitivity to physical contact
  • hallucinations
  • interstitial seizures
  • mood disturbances
  • agitation
  • excitability
  • rage
  • decreased attention span
  • impaired driving ability
  • collapse
  • confusion

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a sealed container. The storage temperature should be kept between 1 and 30 degrees Celsius at room temperature. Storing it this way will help maintain its effectiveness and safety.

Appearance and packaging

Appearance

White rectangular film-coated tablet

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.