Medication info
SLEEP TABLET 5MG (Zolpidem Tartrate)

SLEEP TABLET 5MG (Zolpidem Tartrate)

Prescription medicationTabletOral
Ingredient · strength
Zolpidem Tartrate›5mg / 1 tablet
Manufacturer / importer
Unimed Pharmaceutical Co., Ltd.
Appearance
Purple round film-coated tablets
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201701570 · Approved 2017.03.31 · Insurance code 649507410

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 that occurs 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. Serious injuries or fatal accidents may occur from such behaviors, so caution is advised. If insomnia persists for more than 7-10 days, other mental or physical conditions may be present, and a consultation with a physician is necessary. It is especially important for older individuals to start with the minimum dosage, as high-dose usage may increase the risk of side effects. This medication should not be taken with alcohol or other central nervous system depressants, as the effects can be intensified and may pose a risk. When used with opioid analgesics, serious side effects such as respiratory depression or coma may occur, so caution is essential. Rarely, serious side effects such as allergic reactions or respiratory distress may occur, so if symptoms appear, discontinue use immediately and visit a hospital. Women who are pregnant or planning to become pregnant should consult with a physician before using this medication, and it is advisable to avoid use while breastfeeding. Safety and effectiveness have not been established in children and adolescents under 18 years of age, so it should not be administered. During use of this medication, tasks that require concentration, such as driving or operating machinery, should be avoided, and adequate sleep time should be ensured. Drowsiness or dizziness may occur after taking the medication, so caution should be exercised to avoid falls or injuries during such times. Suddenly stopping the medication may lead to withdrawal symptoms such as anxiety and worsening insomnia, so dosage should be gradually reduced according to a physician's instructions. This medication can cause dependence, so long-term use should be avoided, strictly following a physician's prescription and instructions. If any new unusual behavior or mood changes occur during the use of this medication, consult medical personnel immediately.

Side effects

  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • drowsiness
  • headache
  • dizziness
  • exacerbation of insomnia
  • antegrade amnesia
  • paresthesia
  • tremor
Show 88 more
  • attention deficit
  • speech impairment
  • altered state of consciousness
  • hallucination
  • agitation
  • nightmares
  • depression
  • confusion
  • irritability
  • restlessness
  • aggressiveness
  • somnambulism
  • euphoria
  • sexual dysfunction
  • delusion
  • dependency
  • anger
  • abnormal behavior
  • fatigue
  • gait disturbance
  • falls
  • drug tolerance
  • diplopia
  • visual blurring
  • visual impairment
  • respiratory depression
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • back pain
  • joint pain
  • muscle pain
  • muscle cramps
  • neck pain
  • myasthenia
  • rash
  • itching
  • sweating
  • urticaria
  • angioedema
  • elevated liver enzymes
  • hepatocellular damage
  • cholestatic liver injury
  • upper respiratory infection
  • lower respiratory infection
  • appetite changes
  • tongue angioedema
  • supraglottic angioedema
  • laryngeal angioedema
  • dyspnea
  • throat occlusion
  • nausea
  • vomiting
  • altered consciousness
  • drowsiness
  • stupor
  • cardiovascular system weakening
  • respiratory system weakening
  • headache
  • muscle pain
  • extreme anxiety
  • tension
  • agitation
  • confusion
  • excitability
  • unreality
  • depersonalization
  • auditory hypersensitivity
  • limb paresthesia
  • numbness
  • light hypersensitivity
  • noise hypersensitivity
  • hypersensitivity to physical contact
  • hallucination
  • interictal seizures
  • mood disturbances
  • agitation
  • excitability
  • rage
  • psychomotor retardation
  • impaired driving ability
  • drowsiness
  • prolonged reaction time
  • vertigo
  • blurred vision
  • decreased attention
  • impaired driving ability

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should ideally be maintained at room temperature between 1 to 30 degrees Celsius. Proper storage ensures the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Purple round 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.