Medication info
Zopistar Tablet 1mg (Eszopiclone)

Zopistar Tablet 1mg (Eszopiclone)

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

MFDS item code 201902863 · Approved 2019.05.03 · Insurance code 670608170

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

This medication is primarily used to improve insomnia, which is the difficulty in falling asleep or staying asleep. Insomnia can significantly impair daily life, making appropriate treatment necessary. This drug helps induce stable sleep to assist in achieving 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 that may cause drowsiness or decreased consciousness after taking it, so caution is needed when engaging in dangerous activities such as driving or operating machinery. In addition, the depressant effects may be stronger if taken with other central nervous system depressants or alcohol, so it is advisable not to combine them. It should be taken just before bedtime, and after taking it, caution is required as memory loss, hallucinations, coordination issues, and dizziness may occur. Elderly or weak patients may be more sensitive to this medication, necessitating dosage reduction and careful administration, as the risk of falls is also increased. If sleep disturbances persist for more than 7 to 10 days, there may be an underlying condition, so consultation with a doctor to evaluate the cause is necessary. Serious allergic reactions such as angioedema in the tongue, vocal cords, or larynx, or respiratory distress can occur in patients who are taking this medication for the first time or during treatment, so if such symptoms arise, discontinue use immediately and visit a medical institution. Abnormal behavioral changes, such as increased aggression, hallucinations, or behavior like driving or consuming food while asleep—indicative of unconscious actions—can occur, so if these symptoms arise, discontinue use and consult a specialist. This medication can lead to abuse and dependence, so it should not be used for extended periods, and patients with a history of substance abuse should be particularly cautious. Patients with impaired liver or kidney function may require dosage adjustments, and interactions may occur with certain medications, so it is essential to inform the doctor or pharmacist of any other medications being taken. Pregnant or lactating women must consult a physician before taking this medication, and it should not be used in children under 18 years of age as safety and efficacy have not been established. In cases of overdose, symptoms such as coma or severe central nervous system depression may arise, so the prescribed dosage should not be exceeded, and if overdose is suspected, emergency treatment should be sought immediately. This medication should be stored out of reach of children, kept in its original container, and should not be transferred to a different container.

Side effects

  • Central nervous system depression
  • drowsiness
  • decreased level of consciousness
  • vascular edema
  • anaphylaxis
  • respiratory distress
  • throat obstruction
  • nausea
  • vomiting
  • abnormal aggression
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  • extroversion
  • bizarre behavior
  • anxiety
  • hallucinations
  • depersonalization
  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • amnesia
  • anxiety
  • unusual dreams
  • nausea
  • vomiting
  • anxiety
  • confusion
  • depression
  • dizziness
  • hallucinations
  • decreased libido
  • irritability
  • drowsiness
  • infection
  • rash
  • unpleasant taste
  • dysmenorrhea
  • gynecomastia
  • accidental injury
  • pain
  • diarrhea
  • unusual dreams
  • neuralgia
  • pruritus
  • urinary tract infection
  • chest pain
  • allergic reactions
  • cellulitis
  • facial edema
  • fever
  • halitosis
  • heatstroke
  • hernia
  • discomfort
  • neck stiffness
  • photosensitivity
  • migraine
  • hypertension
  • thrombophlebitis
  • anorexia
  • cholelithiasis
  • increased appetite
  • hematochezia
  • 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
  • convulsions
  • arthrosis
  • myopathy
  • ptosis
  • bulimia
  • numbness
  • ataxia
  • emotional instability
  • hostility
  • hypertonia
  • sensory reduction
  • ataxia
  • insomnia
  • memory impairment
  • neurosis
  • nystagmus
  • perceptual disturbance
  • reduced reflexes
  • abnormal thinking
  • dizziness
  • abnormal gait
  • euphoria
  • hypersensitivity
  • exercise intolerance
  • 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
  • anaphylactoid reaction
  • herpes zoster
  • hypertrichosis
  • granulomatous rash
  • dust-induced rash
  • conjunctivitis
  • dry eyes
  • ear pain
  • otitis externa
  • otitis media
  • tinnitus
  • vestibular disorder
  • hyperacusis
  • iritis
  • pupil dilation
  • photophobia
  • amenorrhea
  • mastitis
  • breast enlargement
  • breast tumors
  • breast pain
  • cystitis
  • dysuria
  • lactating women
  • hematuria
  • kidney stones
  • renal pain
  • mastitis
  • menorrhagia
  • uterine bleeding
  • urinary frequency
  • 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 to protect it from air and moisture, and it is essential to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature. By storing it this way, the efficacy of the medication can be maintained over an extended period.

Appearance and packaging

Appearance

White 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.