Medication info
Silenot 6 mg (Doxepin Hydrochloride)

Silenot 6 mg (Doxepin Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Doxepin Hydrochloride›6.78mg / 1 tablet
Manufacturer / importer
HK inno.N Co., Ltd.
Appearance
Green oval tablet
Packaging
30 tablets per bottle
Approval status
Active

MFDS item code 201310841 · Approved 2013.12.24 · Insurance code 640006770

Summary

Main use
Short-term treatment of insomnia characterized by difficulty maintaining sleep
Who takes it
Adults
Adult dose
Adults: The recommended dose is 6mg once daily; for some patients, 3mg once daily may be appropriate as prescribed by a physician. Older adults 65 years of age and older: The recommended initial dose is 3mg once daily. A maximum of 6mg daily may be administered as prescribed by a physician. Do not exceed the maximum daily dose of 6mg. Take this medicine within 30 minutes before bedtime. To minimize effects on the following day, do not take it within 3 hours after a meal.

Ingredients

Manufacturer
HK inno.N Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia characterized by difficulty maintaining sleep

  • Difficulty maintaining sleep
  • insomnia
View approved original text

This medication is used for the short-term treatment of insomnia with difficulty maintaining sleep.

How to take

Adult dose

Adults: The recommended dose is 6mg once daily; for some patients, 3mg once daily may be appropriate as prescribed by a physician. Older adults 65 years of age and older: The recommended initial dose is 3mg once daily. A maximum of 6mg daily may be administered as prescribed by a physician. Do not exceed the maximum daily dose of 6mg. Take this medicine within 30 minutes before bedtime. To minimize effects on the following day, do not take it within 3 hours after a meal.

Precautions

This medication may be symptomatic of other physical or psychiatric disorders related to sleep disturbances, so the patient's condition should be thoroughly evaluated before use. During the use of this medication, dangerous behaviors such as sleep driving may occur, so driving or operating machinery should be avoided. For patients with depression, there is a risk of worsening suicidal thoughts or actions, so any new behavioral changes should be immediately evaluated by a physician. This medication may cause drowsiness or sedation by suppressing the central nervous system, so dangerous activities should be avoided after intake, and it should not be taken with alcohol or other sedatives. Patients who are hypersensitive to this medication or taking certain medications (MAO inhibitors), as well as those with untreated glaucoma or severe urinary retention, should not take this medication. It should be taken during pregnancy only when absolutely necessary due to potential risks to the fetus, and caution is also needed during breastfeeding. Safety and efficacy have not been established in children, so it is advisable not to use it in this population. Elderly individuals may experience more pronounced sedation and confusion, so they should start at a lower dose and be carefully monitored. Patients with impaired liver function may have higher blood drug concentrations, so treatment should start at a lower dose and be monitored closely. This medication is not recommended for patients with severe sleep apnea, and although the risk of drug abuse or dependency is low, signs of drug abuse should be carefully monitored during use. In the case of overdose, severe side effects may occur, and immediate medical attention should be sought for appropriate treatment.

Side effects

drowsiness, sedation, upper respiratory tract infection, pharyngitis, gastroenteritis, nausea, hypertension, anemia, thrombocytosis, heart block, palpitations, tachycardia, premature ventricular contraction, ear pain, hearing loss, motion sickness, tinnitus, tympanic membrane perforation, congestion, blurred vision, eyelid spasm, double vision, eye pain, decreased lacrimation, abdominal pain, dry mouth, gastroesophageal reflux, vomiting, indigestion, constipation, gum infiltration, bloody stool, perioral vesicles, weakness, chest pain, fatigue, chills, walking abnormalities, peripheral edema, hyperbilirubinemia, hypersensitivity reaction, bronchitis, fungal infection, laryngitis, sinusitis, dental infection, urinary tract infection, viral infection, soft tissue infection, eye infection, folliculitis, viral gastroenteritis, herpes zoster, tendon tenosynovitis, influenza, lower respiratory tract infection, onychomycosis, pharyngitis, pneumonia, abdominal wall injury, falls, joint sprain, fracture, skin laceration, increased blood glucose, elevated ALT, decreased blood pressure, increased blood pressure, abnormal ST-T segment on electrocardiogram, abnormal QRS complex on electrocardiogram, decreased heart rate, decreased neutrophil count, abnormal QRS axis on electrocardiogram, increased aminotransferase, loss of appetite, appetite decrease, hyperkalemia, hypermagnesemia, increased appetite, hypokalemia, joint pain, back pain, myalgia, neck pain, limb pain, decreased joint range of motion, muscle cramps, asthenia, stage 1 lung adenocarcinoma, malignant melanoma, dizziness, taste disturbance, excessive drowsiness, paresthesia, syncope, taste loss, ataxia, cerebrovascular accident, attention deficit, migraine, sleep paralysis, vasovagal syncope, tremor, abnormal dreams, adjustment disorder, anxiety, depression, confusional state, euphoric mood, insomnia, decreased libido, nightmares, breast cyst, dysmenorrhea, urinary difficulty, nocturnal enuresis, hemoglobinuria, nocturia, congestion, throat pain, sinus congestion, wheezing, cough, foul breath, pharyngeal disorder, runny nose, dyspnea, skin irritation, cold sweat, dermatitis, erythema, hyperhidrosis, pruritus, rash, rosacea, pallor, uncontrolled blood pressure, hematoma, facial flushing, constipation, urinary retention, orientation disturbance, hallucination, numbness, sensory disturbance, extrapyramidal symptoms, seizure, delayed onset akathisia, aphthous stomatitis, indigestion, increased libido, testicular swelling, gynecomastia, excessive milk secretion, breast enlargement, increased blood glucose, decreased blood glucose, syndrome of inappropriate antidiuretic hormone secretion, tinnitus, weight gain, sweating, flushing, jaundice, hair loss, exacerbation of asthma, high fever, confusion, concentration disorder, transient hallucination, pupil dilation, restlessness, hyperactive reflex, stupor, drowsiness, muscle rigidity, vomiting, decreased body temperature, high fever

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius, which helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Green oval tablet

Package unit

30 tablets per 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.