Medication info
Zopishta Tablet 2 Milligrams (Eszopiclone)

Zopishta Tablet 2 Milligrams (Eszopiclone)

Prescription medicationTabletOral
Ingredient · strength
Eszopiclone›2mg / 1 tablet
Manufacturer / importer
Huons Co., Ltd.
Appearance
Light blue round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201902864 · Approved 2019.05.03 · Insurance code 670608180

Summary

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

Ingredients

Manufacturer
Huons Co., Ltd.

Efficacy & effects

Treatment of insomnia

  • Insomnia
View approved original text

Insomnia refers to the condition of having difficulty falling asleep or maintaining sleep. This medication is used to alleviate symptoms of insomnia and induce restful sleep.

How to take

Adult dose

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

Precautions

This medication has a central nervous system depressant effect and may affect activities the following day if taken in high doses. Special attention is needed when performing tasks such as driving or operating machinery. The depressant effect may be intensified when taken concurrently with other central nervous system depressants or alcohol, thus dosage adjustment is required. Taking this medication with other sleep aids at bedtime or late at night is not recommended. If sufficient sleep time is not secured after taking the medication or if the recommended dosage is exceeded, the risk of mental and motor impairment the next day may increase. Elderly or frail patients should be cautious as this medication may increase the risk of falls due to drowsiness or decreased consciousness. If sleep disturbances persist, a professional evaluation is necessary as they may be caused by another physical or mental disorder. Serious allergic reactions such as swelling of the tongue, larynx, or breathing difficulties, nausea, and vomiting may occur during the first use or continuous use of this medication, so immediate consultation with healthcare professionals is required. Abnormal behavior changes, aggressiveness, hallucinations, and behaviors such as driving or eating while asleep may occur; in such instances, the medication should be discontinued. There is a risk of abuse or dependency, so patients with a history of psychosis or substance abuse should use it cautiously. This medication should be taken just before bedtime, and if taken while awake, it may cause memory loss, hallucinations, dizziness, etc. It should not be administered to those with hypersensitivity, under 18 years of age, acute respiratory failure, or certain hereditary metabolic disorders. For the elderly or frail patients, the dosage should be reduced, and patients with liver impairment also require dose adjustments. Use during pregnancy or breastfeeding should be discussed with a specialist as the effects on the fetus or infant are not clearly known. In case of overdose, decreased consciousness or coma may occur, and immediate emergency treatment is necessary. This medication should be stored out of reach of children and kept in its original container for safety.

Side effects

  • Headache
  • viral infection
  • dry mouth
  • indigestion
  • nausea
  • vomiting
  • anxiety
  • confusion
  • depression
  • dizziness
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  • 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
  • stiff neck
  • photosensitivity
  • migraine
  • hypertension
  • thrombophlebitis
  • anorexia
  • cholelithiasis
  • increased appetite
  • blood in stool
  • oral ulcer
  • thirst
  • ulcerative stomatitis
  • colitis
  • dysphagia
  • gastritis
  • hepatitis
  • liver enlargement
  • 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
  • convulsions
  • arthropathy
  • myopathy
  • ptosis
  • shaking
  • asthma
  • bronchitis
  • shortness of breath
  • epistaxis
  • hiccups
  • laryngitis
  • acne
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • skin discoloration
  • sweating
  • urticaria
  • erythema multiforme
  • ichthyosis
  • herpes zoster
  • hirsutism
  • granuloma annulare rash
  • pityriasis rosea rash
  • conjunctivitis
  • dry eyes
  • ear pain
  • otitis externa
  • otitis media
  • tinnitus
  • vestibular disorders
  • auditory hyper-sensitivity
  • iritis
  • pupil dilation
  • photophobia
  • amenorrhea
  • mastitis
  • breast enlargement
  • breast tumor
  • breast pain
  • cystitis
  • urinary disorders
  • female lactation
  • hematuria
  • kidney stones
  • kidney pain
  • mastitis
  • hypermenorrhea
  • uterine bleeding
  • frequency of urination
  • urinary incontinence
  • uterine bleeding
  • vaginal bleeding
  • vaginitis
  • oliguria
  • pyelonephritis
  • urethritis
  • hyposmia

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

Storage

This medication should be stored in a sealed container that can protect it from air and moisture. It is recommended to store it at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Light 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.