Medication info

Sleepin 6 mg (Doxepin Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Doxepin Hydrochloride›Strength being verified
Manufacturer / importer
Kyungdong Pharmaceutical Co., Ltd.
Appearance
Green oval-shaped tablets
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201702045 · Notified 2017.04.24

This product's status changed to Approval withdrawn on 2023.03.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Short-term treatment of insomnia with difficulty maintaining sleep
Who uses it
Adults
Adult dosage
Adults: The recommended dose of this medicine is 6mg once daily. For some patients, 3mg once daily may be appropriate, as prescribed by a physician. Older adults aged 65 years or older: The recommended initial dose of this medicine is 3mg once daily. The dose may be increased to a maximum of 6mg daily as prescribed by a physician. Do not take more than 6mg of this medicine per day. Take this medicine within 30 minutes before bedtime and do not take it within 3 hours after a meal, to minimize effects on the following day.

Ingredients

Manufacturer
Kyungdong Pharmaceutical Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia with difficulty maintaining sleep

  • Difficulty maintaining sleep
  • insomnia
View approved original text

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

Dosage and Administration

Adult dosage

Adults: The recommended dose of this medicine is 6mg once daily. For some patients, 3mg once daily may be appropriate, as prescribed by a physician. Older adults aged 65 years or older: The recommended initial dose of this medicine is 3mg once daily. The dose may be increased to a maximum of 6mg daily as prescribed by a physician. Do not take more than 6mg of this medicine per day. Take this medicine within 30 minutes before bedtime and do not take it within 3 hours after a meal, to minimize effects on the following day.

Precautions

This medication may be a symptom of other physical or psychiatric disorders, so the patient's condition should be thoroughly evaluated before use. If insomnia does not improve after taking this medication for 7-10 days, it may indicate the presence of other psychiatric or internal medical conditions requiring further investigation. While taking this medication, new unusual behaviors or changes in cognitive function may occur, and if such symptoms arise, it is important to consult a doctor immediately. There may be actions such as driving or eating while not fully awake after taking this medication, and these actions might not be remembered by the patient. This medication can increase the risk of suicidal thoughts or behaviors in patients with depression, so if depressive symptoms worsen or unusual behaviors occur, consult medical personnel immediately. After taking the medication, it is advisable to limit activities in preparation for sleep and avoid dangerous actions, such as driving or operating machinery. Taking this medication with alcohol, antihistamines, or other central nervous system depressants can enhance sedative effects and increase the risk of side effects, so they should not be taken together. Patients with allergies to the drug or its components or those taking certain medications (MAO inhibitors), as well as patients with untreated glaucoma or significant urinary difficulties, should not take this medication. During use, various side effects such as drowsiness, sedation, dizziness, nausea, blood pressure changes, etc. may occur, and persistent abnormal symptoms should be reported to medical personnel. Pregnant or breastfeeding women should consult a doctor before taking this medication, as it may affect the fetus or the baby. Safety in children has not been established, so it is not recommended for pediatric use. Elderly patients may be more sensitive to this medication, so dosage adjustments and careful monitoring are necessary. Patients with poor liver function may have elevated drug concentrations in the blood; therefore, it is advised to start at a lower dose and carefully monitor their condition. Patients with compromised respiratory function, especially those with severe sleep apnea, should avoid taking this medication due to the risk of respiratory depression. This medication has a relatively low potential for abuse or dependence, but unusual behavior or drug use habits should be closely monitored during treatment. Overdose may result in severe cardiac issues, central nervous system abnormalities, gastrointestinal problems, etc., and immediate emergency treatment is required.

Side effects

Drowsiness, sedation, upper respiratory tract infection, pharyngitis, colitis, 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, urination reduction, abdominal pain, dry mouth, gastroesophageal reflux, vomiting, dyspepsia, constipation, gum swelling, blood in stool, oral vesicles, weakness, chest pain, fatigue, chills, gait 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, shingles, tendonitis, influenza, lower respiratory tract infection, onychomycosis, pharyngitis, pneumonia, abdominal injury, falls, joint sprain, fracture, skin laceration, increased blood glucose, elevated ALT, decreased blood pressure, increased blood pressure, ECG ST-T segment abnormalities, ECG QRS complex abnormalities, decreased heart rate, decreased neutrophil count, ECG QRS axis abnormalities, increased amino transferase, loss of appetite, decreased appetite, hyperkalemia, hypermagnesemia, increased appetite, hypokalemia, joint pain, back pain, muscle pain, neck pain, pain in limbs, decreased joint range of motion, muscle cramps, lethargy, stage 1 lung adenocarcinoma, malignant melanoma, dizziness, taste disorder, somnolence, numbness in hands and feet, syncope, loss of taste, ataxia, cerebrovascular accident, attention deficit disorder, migraine, sleep paralysis, neurally mediated hypotension, tremors, abnormal dreams, adjustment disorder, anxiety, depression, confusion, elevated mood, insomnia, decreased libido, nightmares, breast cysts, dysmenorrhea, dysuria, enuresis, hemoglobinuria, nocturia, congestion, throat pain, sinus congestion, wheezing, cough, dysphonia, 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, disorientation, hallucinations, numbness, sensory disturbance, extrapyramidal symptoms, seizures, delayed onset movement disorder, hypotension, aphthous stomatitis, dyspepsia, increased libido, scrotal 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

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

Storage

This medication may be sensitive to air and light, so it should be stored in a tightly sealed container. It is advisable to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. This will help preserve the medication's efficacy and safety for an extended period.

Appearance and packaging

Appearance

Green oval-shaped tablets

Package unit

30 tablets/bottle, 200 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.