Medication info

Rich Night Tablet 6 mg (Doxepin Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Doxepin Hydrochloride›Strength being verified
Manufacturer / importer
Poonglim Pharmaceutical Co., Ltd.
Appearance
Green oval-shaped tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201605587 · Notified 2016.09.21

This product's status changed to Approval withdrawn on 2023.03.27. 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 medication is 6 mg once daily; for some patients, 3 mg once daily may be appropriate as prescribed by a physician. Elderly patients aged 65 years and older: The recommended initial dose of this medication is 3 mg once daily. As prescribed by a physician, a maximum of 6 mg daily may be administered. Do not administer more than 6 mg of this medication per day. This medication should be taken within 30 minutes before bedtime and should not be taken within 3 hours after a meal to minimize effects on the following day.

Ingredients

Manufacturer
Poonglim Pharmaceutical Co., Ltd.

Efficacy & effects

Short-term treatment of insomnia with difficulty maintaining sleep

  • Insomnia with difficulty maintaining sleep
View approved original text

This medication is used for patients with insomnia who have difficulty maintaining sleep. It improves the quality of sleep over a short period, helping to provide more stable and restful sleep. It acts quickly to alleviate problems such as difficulty falling asleep or frequently waking up. As a result, it reduces daytime fatigue and enhances vitality in daily life. Therefore, it is used as a treatment that provides short-term assistance to individuals with sleep problems.

Dosage and Administration

Adult dosage

Adults: The recommended dose of this medication is 6 mg once daily; for some patients, 3 mg once daily may be appropriate as prescribed by a physician. Elderly patients aged 65 years and older: The recommended initial dose of this medication is 3 mg once daily. As prescribed by a physician, a maximum of 6 mg daily may be administered. Do not administer more than 6 mg of this medication per day. This medication should be taken within 30 minutes before bedtime and should not be taken within 3 hours after a meal to minimize effects on the following day.

Precautions

This medication may be a symptom of sleep disorders related to other physical or psychiatric conditions, so it is important to thoroughly assess the patient's overall health prior to use. If insomnia does not improve after 7 to 10 days of use, there may be a possibility of other psychiatric or internal diseases, and a consultation with a specialist is advised. This medication may lead to amnesic behaviors during sleep, such as driving or eating, so it is crucial to avoid dangerous activities after taking it. Taking it in conjunction with alcohol or other central nervous system depressants may increase the risk of abnormal behaviors and must be strictly avoided. In patients with depression, the risk of suicidal thoughts or behaviors may worsen while taking this medication, and any new behavioral changes should be reported to a physician immediately. Drowsiness and sedative effects may occur after taking this medication; hence it should be taken only at night and dangerous activities such as driving or operating machinery should be avoided during the daytime. Caution is necessary when taking this medication with alcohol, antihistamines, or other central nervous system depressants, as it may enhance sedative effects. Patients with allergies to this medication or its ingredients, those taking specific medications, or those who have certain ocular disorders or urinary retention should not take this medication. During pregnancy, this medication may affect the fetus, so its use should be determined based on a physician’s judgment. While breastfeeding, this medication can be passed into breast milk and may affect the baby, so caution is required. In children, safety and efficacy have not been established, and it is advisable not to use this medication. Elderly patients may be more sensitive to this medication; thus, it is recommended to start with a lower dose and carefully adjust the dosage. Patients with impaired liver function may experience increased blood concentrations, so it is necessary to start with a lower dose and closely monitor their condition. Patients with sleep apnea and compromised respiratory function may face the risk of respiratory depression when using this medication, thus it is generally not recommended. While this medication has a low potential for abuse or dependence, any ongoing signs of substance abuse should be reported to medical staff immediately. Overdose can lead to severe side effects, so it is essential to adhere strictly to the dosage and visit a medical institution immediately if any abnormal symptoms arise.

Side effects

Drowsiness, sedation, upper respiratory infection, pharyngitis, gastritis, nausea, hypertension, anemia, thrombocytosis, heart block, palpitations, tachycardia, ventricular extrasystole, ear pain, hearing loss, motion sickness, tinnitus, tympanic membrane perforation, congestion, blurry vision, eyelid spasm, double vision, eye pain, decreased urination, abdominal pain, dry mouth, gastroesophageal reflux, vomiting, dyspepsia, constipation, gum recession, 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, herpes zoster, tenosynovitis, influenza, lower respiratory infection, onychomycosis, pharyngitis, pneumonia, abdominal injury, falls, joint sprains, fractures, skin laceration, increased blood glucose, ALT elevation, 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 aminotransferases, loss of appetite, decreased appetite, hyperkalemia, hypermagnesemia, increased appetite, hypokalemia, joint pain, back pain, muscle pain, neck pain, limb pain, decreased range of motion in joints, muscle cramps, lethargy, stage 1 lung adenocarcinoma, malignant melanoma, dizziness, taste disturbances, somnolence, paresthesia, syncope, loss of taste, ataxia, cerebrovascular accident, attention deficit, migraine, sleep paralysis, vasovagal syncope, tremor, abnormal dreams, adjustment disorder, anxiety, depression, confusion, euphoric mood, insomnia, decreased libido, nightmares, breast cyst, dysmenorrhea, dysuria, polyuria, hemoglobinuria, nocturia, congestion, sore throat, sinus congestion, wheezing, cough, confusional state, pharyngeal disorder, rhinorrhea, breathing difficulties, skin irritation, cold sweat, dermatitis, erythema, hyperhidrosis, itching, rash, rosacea, pallor, uncontrolled blood pressure, hematoma, facial flushing, constipation, urinary retention, disorientation, hallucinations, numbness, sensory disturbances, extrapyramidal symptoms, seizures, delayed onset movement disorder, aphthous stomatitis, dyspepsia, 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 difficulties, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, confusion, drowsiness, muscle rigidity, vomiting, hypothermia, 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. It is advised to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way ensures the medication's effectiveness is safely maintained.

Appearance and packaging

Appearance

Green oval-shaped 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.