Medication info
Melatonin Extended Release Tablet 2 mg (Melatonin)

Melatonin Extended Release Tablet 2 mg (Melatonin)

Prescription medicationTablet경구
Ingredient · strength
Melatonin›2mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
White to grayish-white round extended-release tablet
Packaging
30 tablets/box [(10 tablets/PTP)*3]
Approval status
Active

MFDS item code 202500106 · Approved 2025.01.14

Summary

Main use
Treatment for improving sleep quality in patients with insomnia over the age of 55
Who takes it
Adults
Adult dose
Take 1 tablet orally once daily, 1 to 2 hours before bedtime after meals, without chewing or crushing the tablet.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Treatment for improving sleep quality in patients with insomnia over the age of 55

  • Decreased sleep quality
  • insomnia
View approved original text

This medication is used for short-term treatment of insomnia in patients over the age of 55 with deteriorated sleep quality. It helps improve difficulties in falling asleep and frequent awakenings during sleep, thereby aiding restful sleep. This increases overall sleep quality and helps alleviate fatigue and decreased concentration during the day. It is suitable for short-term use and safely improves insomnia symptoms.

How to take

Adult dose

Take 1 tablet orally once daily, 1 to 2 hours before bedtime after meals, without chewing or crushing the tablet.

Precautions

This medication should not be taken by patients with allergies to this medication or any of its ingredients. Additionally, it contains lactose, so patients with specific genetic disorders that prevent lactose digestion should not use it. Patients with kidney or liver problems should use this medication with caution, and those with autoimmune diseases or who are pregnant or breastfeeding should also take care. Taking this medication may cause symptoms such as headache, nasopharyngitis, back pain, and joint pain, and a variety of side effects have been reported, including rare occurrences of blood abnormalities, hypersensitivity reactions, psychiatric symptoms, digestive disorders, and skin rashes. This medication can cause drowsiness, so caution should be exercised in situations where the risk of accidents due to drowsiness is high. This medication may interact with enzymes metabolized in the liver, potentially altering drug concentrations when taken with other medications; therefore, if you are taking any other medications, you must consult your doctor or pharmacist. Caution is particularly necessary when used together with drugs such as fluvoxamine, methoxsalen, estrogen preparations, and cimetidine. Taking this medication with alcohol may reduce its effectiveness, so it is advisable not to take them together. When taken with other sleeping pills such as zolpidem, the sedative effect may be increased, so care should be taken. Pregnant or breastfeeding women are advised not to take this medication. The safety and efficacy in children under the age of 18 have not been established. Care should be taken while driving or operating hazardous machinery as this medication may cause drowsiness, which could lead to accidents.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • oral edema
  • tongue swelling
  • angina
  • high bilirubinemia
  • thrombocytopenia
  • leukopenia
  • severe allergic reactions
  • severe skin adverse reactions
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  • respiratory problems
  • liver abnormalities (jaundice)
  • severe neurological symptoms
  • severe edema
  • or urinary abnormalities.

Mild side effects

  • Headache
  • nasopharyngitis
  • back pain
  • joint pain
  • hypertriglyceridemia
  • hypocalcemia
  • hyponatremia
  • hypersensitivity
  • nervousness
  • agitation
Show 22 more
  • insomnia
  • abnormal dreams
  • nightmares
  • anxiety
  • mood changes
  • aggression
  • crying
  • stress symptoms
  • disorientation
  • early morning awakening
  • increased libido
  • depressed mood
  • depression
  • migraine
  • drowsiness
  • mental overactivity
  • dizziness
  • sleepiness
  • fainting
  • memory impairment
  • attention deficit
  • lethargy.

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

Storage

This medication may be sensitive to light, so it should be stored in a container that blocks light. It is also recommended to store it in a cool place at or below room temperature (25 degrees Celsius).

Appearance and packaging

Appearance

White to grayish-white round extended-release tablet

Package unit

30 tablets/box [(10 tablets/PTP)*3]

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.