Medication info

Ezostara 1 mg Tablets (Eszopiclone)

Prescription medicationTabletOralApproval withdrawn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Approval withdrawn

MFDS item code 202203440 · 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This product's status changed to Approval withdrawn on 2024.03.28.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 medication is used to improve insomnia, specifically the difficulty in falling asleep or frequently waking up.

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 induce sedation and sleep effects. Drowsiness may occur after taking it; therefore, caution should be taken when driving or operating dangerous machinery the next day. This risk may be greater with high doses. Additionally, it should be avoided in combination with alcohol or other central nervous system depressants as it may amplify effects and pose dangers. It is crucial to take this medication just before bedtime; taking it while awake may lead to side effects such as amnesia or hallucinations. This medication is not to be administered to patients with certain conditions, such as severe respiratory failure, lactose intolerance, or those under 18 years of age. Patients who have previously experienced complex sleep behaviors (e.g., driving or preparing food while asleep) after taking this medication should also refrain from its use. Elderly or debilitated patients may be more sensitive to this medication and should use it with caution at reduced doses. Patients with impaired liver or kidney function also need to exercise caution. For patients with depression, there is a risk of suicide, and it should be administered at the minimum effective dose with careful monitoring. Rarely, this medication may cause severe allergic reactions or angioedema. If swelling of the tongue or throat, or difficulty breathing occurs, immediate medical attention should be sought. During use, abnormal behavioral changes such as aggression, hallucinations, or anxiety may arise. If any of these symptoms occur, the medication should be stopped immediately, and a doctor should be consulted. Prolonged use may lead to tolerance to the drug and risks of abuse and dependence; it must be taken strictly according to a doctor's instructions. In case of overdose, severe symptoms such as reduced consciousness or respiratory depression may occur; immediate emergency treatment is needed if an overdose is suspected. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or deterioration.

Side effects

  • Central nervous system inhibition
  • daytime activity disorder
  • drowsiness
  • decreased level of consciousness
  • vascular edema
  • anaphylactic reaction
  • dyspnea
  • throat obstruction
  • nausea
  • vomiting
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  • abnormal thoughts and behavioral changes
  • aggressiveness
  • extroversion
  • bizarre behavior
  • restlessness
  • hallucinations
  • depersonalization
  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • amnesia
  • anxiety
  • unusual dreams
  • nausea
  • vomiting
  • anxiety
  • confusion
  • depression
  • dizziness
  • hallucinations
  • decreased libido
  • irritability
  • drowsiness
  • infections
  • rash
  • unpleasant taste
  • dysmenorrhea
  • gynecomastia
  • accidental injuries
  • pain
  • diarrhea
  • abnormal dreams
  • neuralgia
  • pruritus
  • urinary tract infection
  • chest pain
  • allergic reaction
  • cellulitis
  • facial swelling
  • fever
  • halitosis
  • heat stroke
  • hernia
  • discomfort
  • neck rigidity
  • photosensitivity
  • migraine
  • hypertension
  • thrombophlebitis
  • anorexia
  • cholelithiasis
  • increased appetite
  • hematochezia
  • oral ulcers
  • 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
  • convulsion
  • numbness
  • ataxia
  • emotional instability
  • hostility
  • increased tension
  • sensory diminution
  • ataxia
  • insomnia
  • memory impairment
  • neurosis
  • nystagmus
  • perceptual dysfunction
  • reflex reduction
  • abnormal thought patterns
  • dizziness
  • abnormal gait
  • euphoria
  • hypersensitivity reactions
  • decreased motor function
  • neuritis
  • neurological disorders
  • clouding of consciousness
  • tremor
  • asthma
  • bronchitis
  • dyspnea
  • epistaxis
  • hiccups
  • laryngitis
  • acne
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • skin discoloration
  • sweating
  • urticaria
  • erythema multiforme
  • acanthosis
  • herpes zoster
  • hirsutism
  • granuloma annulare rash
  • papular rash
  • conjunctivitis
  • dry eye
  • ear pain
  • otitis externa
  • otitis media
  • tinnitus
  • vestibular disorder
  • auditory hyperesthesia
  • iritis
  • dilated pupils
  • photophobia
  • amenorrhea
  • mastalgia
  • breast enlargement
  • breast tumor
  • breast pain
  • cystitis
  • voiding dysfunction
  • female lactation
  • hematuria
  • kidney stones
  • kidney pain
  • mastitis
  • menorrhagia
  • uterine bleeding
  • urinary frequency
  • incontinence
  • uterine bleeding
  • vaginal bleeding
  • vaginitis
  • oliguria
  • pyelonephritis
  • urethritis
  • olfactory disorder

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

Storage

This medication should be stored in a tightly sealed container to protect it from air or moisture, ideally in a cool room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and safety.

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

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.