Medication info

Farmaes Zolpidem Tablets 1mg

Prescription medicationTabletOralApproval withdrawn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Approval withdrawn

MFDS item code 202103386 · Approved 2021.04.26

This product's status changed to Approval withdrawn on 2024.03.27. 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 taking this medication may impair driving or other activities that require full alertness the following day, take it once immediately before bedtime and allow at least 7-8 hours between taking the medication and getting up. 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 potent CYP3A4 inhibitors, do not exceed 2mg per day. (See Interactions.) For patients taking central nervous system depressants, dosage 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
Korea Pharma Co., Ltd.

Efficacy & effects

Treatment of insomnia

  • Insomnia
View approved original text

This medication is used for 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 taking this medication may impair driving or other activities that require full alertness the following day, take it once immediately before bedtime and allow at least 7-8 hours between taking the medication and getting up. 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 potent CYP3A4 inhibitors, do not exceed 2mg per day. (See Interactions.) For patients taking central nervous system depressants, dosage 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 on the central nervous system and has a sedative and sleep-inducing effect. Drowsiness may occur after taking it, so caution is needed when driving or operating machinery the next day. Taking it with other central nervous system depressants or alcohol may enhance its effects and pose risks, so concurrent use should be avoided or dosage adjustments are necessary. Especially, it is not recommended to take it with other sleeping pills at bedtime. This medication may cause symptoms such as memory loss, hallucinations, abnormal behavioral changes, or complex sleep-related behaviors performed unconsciously. If such symptoms occur, discontinue use immediately and consult a specialist. Elderly or frail patients may respond more sensitively to this medication, increasing the risk of falls, so a lower dose should be used with caution. If sleep disturbances persist or worsen, there may be other physical or mental disorders that require evaluation by a specialist. This medication may cause serious side effects such as allergic reactions or severe angioedema, so patients with hypersensitivity should not take it. Pregnant or nursing women should consult a doctor before use, as the safety of this medication has not been sufficiently established. It is not used in children under 18 as its safety and efficacy have not been established. Overdose may lead to serious symptoms such as coma or respiratory depression, so the prescribed dosage and method must be adhered to. If an overdose is suspected, seek medical attention immediately. This medication should be stored in its original container and kept out of reach of children.

Side effects

  • Central nervous system suppression
  • behavioral disorders
  • drowsiness
  • decreased level of consciousness
  • vascular edema
  • anaphylactic reactions
  • respiratory distress
  • throat obstruction
  • nausea
  • vomiting
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  • abnormal thoughts and behavior changes
  • reduced inhibition
  • aggression
  • extroversion
  • bizarre behavior
  • anxiety
  • hallucinations
  • depersonalization
  • sleepwalking
  • sleep driving
  • complex sleep behaviors
  • amnesia
  • anxiety
  • atypical dreams
  • nausea
  • gastrointestinal disorders
  • headaches
  • viral infections
  • dry mouth
  • dyspepsia
  • nausea
  • vomiting
  • anxiety
  • confusion
  • depression
  • dizziness
  • hallucinations
  • decreased libido
  • irritability
  • drowsiness
  • infections
  • rashes
  • unpleasant taste
  • menstrual pain
  • gynecomastia
  • accidental injuries
  • pain
  • diarrhea
  • abnormal dreams
  • neuralgia
  • pruritus
  • urinary tract infections
  • chest pain
  • allergic reactions
  • fasciitis
  • facial swelling
  • fever
  • halitosis
  • heatstroke
  • hernias
  • malaise
  • neck stiffness
  • photosensitivity
  • migraines
  • hypertension
  • thrombophlebitis
  • anorexia
  • cholelithiasis
  • increased appetite
  • bloody stools
  • oral ulcers
  • 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 diseases
  • leg cramps
  • myasthenia gravis
  • convulsions
  • arthropathy
  • myopathy
  • ptosis
  • hypertonia
  • numbness
  • ataxia
  • emotional instability
  • hostility
  • increased tension
  • sensory loss
  • ataxia
  • insomnia
  • memory impairment
  • neurosis
  • nystagmus
  • perceptual anomalies
  • reduced reflexes
  • abnormal thinking
  • dizziness
  • abnormal gait
  • euphoria
  • hypersensitivity
  • reduced motor function
  • neuritis
  • neurological disorders
  • clouded consciousness
  • tremors
  • asthma
  • bronchitis
  • respiratory distress
  • epistaxis
  • hiccups
  • laryngitis
  • acne
  • alopecia
  • contact dermatitis
  • dry skin
  • eczema
  • skin pigmentation
  • sweating
  • urticaria
  • erythema multiforme
  • decubitus ulcers
  • herpes zoster
  • hypertrichosis
  • granuloma annulare rash
  • dust mite rash
  • conjunctivitis
  • dry eyes
  • ear pain
  • otitis externa
  • otitis media
  • tinnitus
  • vestibular disorders
  • auditory hyperesthesia
  • iritis
  • pupillary dilation
  • photophobia
  • amenorrhea
  • mastitis
  • breast enlargement
  • breast tumors
  • breast pain
  • cystitis
  • voiding disorders
  • lactation in women
  • hematuria
  • kidney stones
  • renal pain
  • mastitis
  • menorrhagia
  • uterine bleeding
  • urinary frequency
  • incontinence
  • uterine bleeding
  • vaginal bleeding
  • vaginitis
  • oliguria
  • pyelonephritis
  • urethritis
  • olfactory dysfunction

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, at a temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

White round film-coated tablets

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.