Medication info

Slim Night Mini Sustained-Release Tablet 1mg (Melatonin)

Prescription medicationTablet경구
Ingredient · strength
Melatonin Micronized›1mg / 1 tablet
Manufacturer / importer
건일제약(주)
Appearance
Pink, bilaterally convex, round sustained-release film-coated tablet with a diameter of 3 millimeters
Packaging
30 tablets/box [(30 tablets/blister pack)], 60 tablets/box [(30 tablets/blister pack * 2)]
Approval status
Active

MFDS item code 202303144 · Approved 2023.11.15

Summary

Main use
Treatment of insomnia in patients with autism spectrum disorder and Smith-Magenis syndrome (children and adolescents)
Who takes it
Adults
Adult dose
The recommended initial dosage is 2 mg once daily. If an insufficient response is observed, it can be increased to 5 mg, with a maximum daily dose of 10 mg. Administer orally once daily 0.5 to 1 hour before bedtime, with food or after meals, and swallow whole without chewing or crushing. This medication is a sustained-release formulation that controls the rate and time of active ingredient release in the body, so it must be swallowed whole without chewing or crushing.

Ingredients

Importer
건일제약(주)

Efficacy & effects

Treatment of insomnia in patients with autism spectrum disorder and Smith-Magenis syndrome (children and adolescents)

  • Insomnia
View approved original text

This medication is used for the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder or Smith-Magenis syndrome who do not improve with sleep hygiene.

How to take

Adult dose

The recommended initial dosage is 2 mg once daily. If an insufficient response is observed, it can be increased to 5 mg, with a maximum daily dose of 10 mg. Administer orally once daily 0.5 to 1 hour before bedtime, with food or after meals, and swallow whole without chewing or crushing. This medication is a sustained-release formulation that controls the rate and time of active ingredient release in the body, so it must be swallowed whole without chewing or crushing.

Precautions

This medication should not be used by patients with allergies to this medication or its components. This medication contains lactose, so patients with genetic diseases that cause lactose intolerance should not take it. Patients with kidney or liver function problems should use this medication with special caution. Patients with autoimmune diseases or women who are pregnant or breastfeeding, as well as children under 2 years of age, should use this medication carefully. Taking this medication may cause side effects such as drowsiness, fatigue, headache, and mood changes, so caution is needed if symptoms occur. This medication may cause drowsiness, so patients should avoid driving or operating hazardous machinery while taking it. There may be interactions when taken with other medications, so it is especially recommended not to combine it with certain antidepressants, sleep aids, or alcohol. Pregnant or breastfeeding women are not recommended to use this medication as its safety has not been sufficiently established. Children under 2 years old should not take this medication as its safety and efficacy have not been established. In the case of overdose, drowsiness may increase, but because this medication is quickly excreted from the body, specific treatment may not be needed. This medication should be stored out of reach of children and in its original container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Shortness of breath, facial swelling → severe allergic reaction

Mild side effects

  • Drowsiness
  • fatigue
  • mood swings
  • headache
  • irritability
  • aggression
  • hangover
  • sinusitis
  • epilepsy
  • vision impairment
Show 12 more
  • nosebleeds
  • constipation
  • decreased appetite
  • facial swelling
  • skin lesions
  • unusual sensations
  • abnormal behavior
  • neutropenia
  • depression
  • nightmares
  • anxiety
  • abdominal pain

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

Storage

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, to maintain the effectiveness of the medication, it is important to store it at room temperature, specifically between 1°C and 30°C.

Appearance and packaging

Appearance

Pink, bilaterally convex, round sustained-release film-coated tablet with a diameter of 3 millimeters

Package unit

30 tablets/box [(30 tablets/blister pack)], 60 tablets/box [(30 tablets/blister pack * 2)]

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.