Medication info

Zopitan 3 mg (Eszopiclone)

Prescription medicationTabletOralExpired
Ingredient · strength
Eszopiclone›3mg / 1 tablet
Manufacturer / importer
Hanin Pharmaceutical Co., Ltd.
Appearance
Blue round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 202007056 · Approved 2020.10.14

This product's status changed to Expired on 2025.10.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of insomnia
Who takes it
Adults
Adult dose
Use the lowest effective dose of this medication. The recommended daily dose for adults is 1mg. If clinically necessary, the dose may be increased to 2-3mg. Because this medication may impair driving or other activities that require full alertness the following day, take it once immediately before bedtime, allowing at least 7-8 hours between taking the medication and waking. Do not exceed the recommended dose of 3mg; take once immediately before bedtime. For elderly or debilitated patients, do not exceed 2mg per day. For patients with severe hepatic impairment or those taking strong CYP3A4 inhibitors, do not exceed 2mg per day (see Interactions). For patients taking central nervous system depressants, dose adjustment may be necessary because of the potential for additive effects. Taking this medication with or immediately after a high-fat/high-calorie meal is expected to slow its absorption and reduce its effect on sleep latency.

Ingredients

Manufacturer
Hanin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of insomnia

  • Insomnia
View approved original text

This medication is used to improve symptoms of sleep disorders, such as insomnia.

How to take

Adult dose

Use the lowest effective dose of this medication. The recommended daily dose for adults is 1mg. If clinically necessary, the dose may be increased to 2-3mg. Because this medication may impair driving or other activities that require full alertness the following day, take it once immediately before bedtime, allowing at least 7-8 hours between taking the medication and waking. Do not exceed the recommended dose of 3mg; take once immediately before bedtime. For elderly or debilitated patients, do not exceed 2mg per day. For patients with severe hepatic impairment or those taking strong CYP3A4 inhibitors, do not exceed 2mg per day (see Interactions). For patients taking central nervous system depressants, dose adjustment may be necessary because of the potential for additive effects. Taking this medication with or immediately after a high-fat/high-calorie meal is expected to slow its absorption and reduce its effect on sleep latency.

Precautions

This medication acts as a central nervous system depressant and may cause impairment in behavior the following day, so caution is advised when engaging in dangerous activities such as driving or operating machinery. Taking this medication with other central nervous system depressants or alcohol may enhance the effects and be hazardous, so it is best to avoid such combinations. This medication should be taken immediately before bedtime, and if awake after taking it, side effects such as memory loss, hallucinations, and dizziness may occur. Elderly patients or those who are frail may react more sensitively to this medicine, increasing the risk of falls, so the dose should be reduced and monitored carefully. If sleep disturbances persist or worsen, there may be other physical or mental disorders, and a doctor’s evaluation should be sought. If serious allergic reactions such as swelling of the tongue, throat, or larynx, or difficulty breathing occur after taking this medication, discontinue use immediately and seek emergency treatment. Complex sleep behaviors, such as driving or eating while not fully awake, may occur, so usage should be stopped immediately if such symptoms arise. This medication may lead to abuse and dependence, so caution is needed to avoid prolonged use or overdose. Patients with impaired liver or kidney function, the elderly, and those with depression should be particularly careful when using this medication, and dosage adjustment may be required. Women who are pregnant or breastfeeding should consult a physician before taking this medication, and it should not be used in children as safety and efficacy have not been established. Overdosage may lead to serious symptoms such as coma or respiratory depression, so it is important to strictly adhere to dosing guidelines and visit the emergency room if overdose is suspected. This medication should be stored out of reach of children, and it is important to keep it in its original container tightly sealed.

Side effects

  • Headache
  • viral infection
  • dry mouth
  • indigestion
  • nausea
  • vomiting
  • anxiety
  • confusion
  • depression
  • dizziness
Show 144 more
  • hallucinations
  • decreased libido
  • irritability
  • drowsiness
  • infection
  • rash
  • unpleasant taste
  • dysmenorrhea
  • gynecomastia
  • accidental injury
  • pain
  • diarrhea
  • abnormal dreams
  • neuralgia
  • pruritus
  • urinary tract infection
  • chest pain
  • allergic reaction
  • cellulitis
  • facial swelling
  • fever
  • halitosis
  • heat stroke
  • hernia
  • discomfort
  • neck stiffness
  • photosensitivity
  • migraine
  • hypertension
  • thrombophlebitis
  • anorexia
  • cholelithiasis
  • increased appetite
  • bloody stools
  • oral ulcer
  • thirst
  • ulcerative stomatitis
  • colitis
  • dysphagia
  • gastritis
  • hepatitis
  • hepatomegaly
  • liver damage
  • gastric ulcer
  • stomatitis
  • tongue swelling
  • rectal bleeding
  • anemia
  • lymphadenopathy
  • peripheral edema
  • hypercholesterolemia
  • weight gain
  • weight loss
  • dehydration
  • gout
  • hyperlipidemia
  • hypokalemia
  • arthritis
  • bursitis
  • joint disease
  • leg cramps
  • myasthenia gravis
  • seizures
  • arthrosis
  • myopathy
  • ptosis
  • agitation
  • numbness
  • ataxia
  • emotional instability
  • hostility
  • hypervigilance
  • sensory impairment
  • ataxia syndrome
  • insomnia
  • memory impairment
  • neurosis
  • nystagmus
  • perceptual disorder
  • decreased reflexes
  • abnormal thinking
  • dizziness
  • abnormal gait
  • euphoria
  • hypersensitivity
  • motor incoordination
  • neuritis
  • neurological disorders
  • clouding of consciousness
  • tremors
  • asthma
  • bronchitis
  • respiratory distress
  • epistaxis
  • hiccups
  • laryngitis
  • acne
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • skin discoloration
  • sweating
  • urticaria
  • erythema multiforme
  • lesions
  • herpes zoster
  • hirsutism
  • granuloma annulare
  • dust mite dermatitis
  • conjunctivitis
  • dry eye
  • ear pain
  • otitis externa
  • otitis media
  • tinnitus
  • vestibular disorder
  • auditory hypersensitivity
  • iritis
  • pupil dilation
  • photophobia
  • amenorrhea
  • mastitis
  • breast enlargement
  • breast tumor
  • breast pain
  • cystitis
  • urinary disorders
  • women's lactation
  • hematuria
  • kidney stones
  • kidney pain
  • mastitis
  • menorrhagia
  • uterine bleeding
  • urinary frequency
  • urinary incontinence
  • uterine bleeding
  • vaginal bleeding
  • vaginitis
  • oliguria
  • pyelonephritis
  • urethritis
  • anosmia

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 and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the medication’s effectiveness.

Appearance and packaging

Appearance

Blue round film-coated tablet

Package unit

30 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.