Medication info

Ezostar 2 mg Tablet (Eszopiclone)

Prescription medicationTabletOralApproval withdrawn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Approval withdrawn

MFDS item code 202203439 · Approved 2022.08.31

This product's status changed to Approval withdrawn on 2024.03.28. 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 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 requiring full alertness the following day, take it once immediately before bedtime, allowing at least 7-8 hours between taking the medicine and waking. Do not exceed the recommended dose of 3mg; take once immediately before bedtime. For elderly or debilitated patients, do not exceed 2mg daily. For patients with severe hepatic impairment or those taking a strong CYP3A4 inhibitor, do not exceed 2mg daily (see Interactions). For patients taking central nervous system depressants, dosage adjustment may be necessary because of the possibility of additive effects. Taking this medicine 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
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of insomnia

  • Insomnia
View approved original text

This medicine is used for insomnia.

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 requiring full alertness the following day, take it once immediately before bedtime, allowing at least 7-8 hours between taking the medicine and waking. Do not exceed the recommended dose of 3mg; take once immediately before bedtime. For elderly or debilitated patients, do not exceed 2mg daily. For patients with severe hepatic impairment or those taking a strong CYP3A4 inhibitor, do not exceed 2mg daily (see Interactions). For patients taking central nervous system depressants, dosage adjustment may be necessary because of the possibility of additive effects. Taking this medicine 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 on the central nervous system to provide a sedative effect; therefore, caution should be exercised when driving or operating machinery the next day after taking it. In particular, taking this medication in high doses or combining it with other central nervous system depressants or alcohol may increase these risks. Additionally, taking this drug with other sleeping pills just before bedtime or during the night is not recommended. Sufficient sleep time should be ensured when taking this medication, and caution should be exercised not to exceed the recommended dosage. This medication may cause drowsiness or diminished consciousness in elderly or frail patients, increasing the risk of falls; these patients should take extra caution. If sleep disturbances persist or worsen, there might be other physical or mental disorders, and a doctor's evaluation is necessary. Rarely, patients who take this medication for the first time or for a long period may experience serious allergic reactions, such as angioedema or anaphylaxis, so if any unusual symptoms occur, use should be stopped immediately and medical attention sought. Complex sleep behaviors, such as driving or eating while not fully awake, may occur; in such cases, the medication should be discontinued immediately. This medication carries the risk of abuse and dependence, so patients with a history of substance abuse or psychiatric disorders should be particularly cautious and treated at the minimum effective dosage. The medication should be taken right before bedtime; taking it while still awake may cause side effects such as amnesia, hallucinations, or dizziness. This medication should not be administered to individuals under the age of 18, patients with acute or severe respiratory failure, or those who are hypersensitive to this medication or its ingredients. Elderly or frail patients, patients with liver dysfunction, or patients with depression should have their dosage adjusted and be closely monitored when using this medication. Women who are pregnant or breastfeeding should consult a doctor before taking this medication and should carefully consider its effects on the fetus or infant. In case of overdose, symptoms like diminished consciousness or respiratory depression may occur, so immediate medical attention is necessary for appropriate treatment. This medication should be kept out of the reach of children and stored in its original container, avoiding transfer to other containers.

Side effects

  • Headache
  • viral infection
  • dry mouth
  • dyspepsia
  • nausea
  • vomiting
  • anxiety
  • confusion
  • depression
  • dizziness
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  • hallucinations
  • decreased libido
  • irritability
  • drowsiness
  • infection
  • rash
  • unpleasant taste
  • menstrual pain
  • gynecomastia
  • accidental injury
  • pain
  • diarrhea
  • abnormal dreams
  • neuralgia
  • pruritus
  • urinary tract infection
  • chest pain
  • allergic reaction
  • 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 edema
  • 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
  • dysgeusia
  • numbness
  • ataxia
  • emotional instability
  • hostility
  • tension
  • sensory impairment
  • ataxic syndrome
  • insomnia
  • memory disturbance
  • neurosis
  • nystagmus
  • perceptual anomaly
  • reflex reduction
  • abnormal thinking
  • dizziness
  • abnormal gait
  • euphoria
  • hypersensitivity
  • exercise intolerance
  • neuritis
  • neurological disorder
  • altered consciousness
  • tremors
  • asthma
  • bronchitis
  • dyspnea
  • epistaxis
  • hiccups
  • laryngitis
  • acne
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • skin discoloration
  • sweating
  • urticaria
  • erythema multiforme
  • palmar erythema
  • herpes zoster
  • hirsutism
  • granuloma annulare rash
  • dust mite rash
  • conjunctivitis
  • dry eye
  • ear pain
  • otitis externa
  • otitis media
  • tinnitus
  • vestibular disorder
  • auditory hyperreactivity
  • iritis
  • pupillary dilation
  • photophobia
  • amenorrhea
  • mastitis
  • breast enlargement
  • breast tumors
  • breast pain
  • cystitis
  • dysuria
  • lactation
  • hematuria
  • kidney stones
  • renal pain
  • mastitis
  • menorrhagia
  • uterine bleeding
  • urinary frequency
  • incontinence
  • uterine bleeding
  • vaginal bleeding
  • vaginitis
  • oliguria
  • pyelonephritis
  • urethritis
  • hypogeusia

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

Storage

This medication should be kept in a tightly sealed container to prevent exposure to air or moisture. It should be stored at room temperature, between 1 and 30 degrees Celsius, away from extremes of heat and cold.

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

No questions yet.

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.