Zaleplon Capsules 10 mg (Zaleplon)

Adult dose

This medicine is administered orally once daily immediately before bedtime, or at bedtime when difficulty falling asleep occurs. The dose should be individualized, and the lowest effective dose should be used. The recommended daily dose is 10 mg. For patients with low body weight, administer 5 mg daily. The risk of certain adverse reactions associated with this medicine is dose-dependent; however, a 20 mg dose is well tolerated and may be considered for some patients who do not respond to lower doses. Doses exceeding 20 mg have not been adequately evaluated and are not recommended. - Elderly and debilitated patients: Because they are more sensitive to the hypnotic effects, the recommended daily dose is 5 mg; do not exceed 10 mg daily. - Patients with hepatic impairment: Because clearance of this medicine is reduced in patients with mild to moderate hepatic impairment, the recommended daily dose is 5 mg. This medicine is not recommended for patients with severe hepatic impairment. - Patients with renal impairment: No dose adjustment is necessary for patients with mild to moderate renal impairment. This medicine has not been studied in patients with severe renal impairment. - When taken with cimetidine, administer an initial dose of 5 mg because clearance of this medicine is reduced. (See 6. Interactions.) Because taking this medicine may impair driving or other activities requiring full alertness the following day, allow at least 7 ~ 8 hours between taking the medicine and getting up. Administration with or immediately after a high-fat/high-calorie meal is expected to delay absorption of this medicine and reduce its effect on sleep latency.

This medication may cause abnormal behaviors while sleeping after administration, such as sleepwalking or driving, which may result in serious injury to oneself or others. These behaviors are often not remembered by the patient, so if abnormal behaviors occur, the medication should be discontinued immediately. As it acts as a central nervous system depressant, taking this medication with other sedatives or alcohol may enhance drowsiness or impair concentration. Therefore, it should only be taken right before bedtime or when experiencing difficulty sleeping, and caution should be exercised the following day during activities that require concentration, such as driving or operating machinery. Especially in elderly patients, there is an increased risk of falls due to drowsiness. If sleep disturbances persist or worsen, it may indicate another underlying physical or mental disorder, requiring assessment by a doctor. Additionally, this medication is contraindicated for patients with hypersensitivity or complex sleep behaviors, acute respiratory failure cases, those under 18 years of age, and patients with certain genetic lactose intolerance. Elderly or frail patients may be more sensitive to this medication, so starting with a lower dose while closely monitoring their condition is recommended. Caution should also be taken in patients with liver or kidney dysfunction, and in depressed patients as thoughts or behaviors related to suicide may worsen, requiring careful administration. This medication can interact with a variety of drugs, so if other medications are being taken, it is important to consult with a doctor or pharmacist. Particular caution is needed when used with alcohol, other central nervous system depressants, certain antibiotics, or antidepressants. Pregnant or breastfeeding women are not recommended to use this medication as its safety has not been established. The safety and efficacy in children have also not been confirmed. In case of overdose, serious symptoms such as drowsiness, coma, and respiratory depression may occur, necessitating immediate medical attention and, if necessary, gastric lavage and supportive treatment. This medication should be stored in a tightly closed container, away from direct sunlight and in a cool place with low humidity, out of reach of children.

Complex sleep behavior, sleepwalking, sleep driving, central nervous system depressant effects, psychomotor disorders, drowsiness, prolonged reaction time, dizziness, blurred vision, double vision, decreased attention, impaired driving, risk of falls, angioedema, tongue swelling, laryngeal edema, laryngeal swelling, respiratory distress, throat obstruction, nausea, vomiting, abnormal aggression, extroversion, bizarre behavior, anxiety, hallucinations, depersonalization, amnesia, seizures, headache, malaise, photosensitivity reactions, appetite suppression, colitis, nausea, peripheral edema, amnesia, confusion, depersonalization, dizziness, hallucinations, hypertonia, sensory reduction, perceptual abnormalities, drowsiness, tremors, vertigo, epistaxis, visual abnormalities, ear pain, eye pain, auditory hypersensitivity, olfactory disturbances, dysmenorrhea, back pain, chest pain, fever, substernal chest pain, chills, facial swelling, generalized edema, hangover effects, neck stiffness, migraine, angina pectoris, block of conduction, hypertension, hypotension, palpitations, syncope, tachycardia, vasodilation, ventricular extrasystole, ectopic heartbeat, cerebral ischemia, cyanosis, pericardial effusion, orthostatic hypotension, pulmonary embolism, bradycardia, thrombophlebitis, ventricular tachycardia, constipation, dry mouth, dyspepsia, belching, esophagitis, bloating, gastritis, gastroenteritis, gingivitis, glossitis, increased appetite, melena, oral ulcer formation, rectal bleeding, stomatitis, aphthous stomatitis, biliary pain, bruxism, pyloric spasms, cheilitis, cholelithiasis, duodenal ulcer, dysphagia, enteritis, gum bleeding, increased salivation, bowel obstruction, abnormal liver function tests, peptic ulcer, tongue discoloration, tongue swelling, ulcerative stomatitis, diabetes, goiter, hypothyroidism, anemia, purpura, lymphadenopathy, eosinophilia, leukocytosis, lymphocytosis, purpura, edema, gout, hypercholesterolemia, thirst, weight gain, hyperbilirubinemia, hyperglycemia, hyperuricemia, hypoglycemia, hypoglycemic reactions, ketosis, lactose intolerance, increased AST, increased ALT, weight loss, arthralgia, arthritis, myalgia, arthrosis, bursitis, joint disorders, myasthenia, tendinitis, myositis, osteoporosis, anxiety, depression, neurosensitivity, abnormal thoughts, gait abnormalities, anxiety, apathy, ataxia, perioral sensory disturbances, emotional instability, abnormal euphoria, sensory hyperreactivity, hyperactivity, hypotonus, coordination disorders, insomnia, reduced libido, neuralgia, nystagmus, central nervous system stimulation, delusions, speech disorders, muscular hypertonia, facial paralysis, hostility, decreased activity, postural muscle spasms, neuropathy, psychomotor retardation, ptosis, decreased reflexes, increased reflexes, sleep talking, sleepwalking, unclear speech, confusion, jaw opening difficulty, bronchitis, asthma, respiratory distress, laryngitis, pneumonia, snoring, changes in voice, apnea, hiccups, hyperventilation, pleural effusion, increased phlegm, itching, rash, acne, hair loss, contact dermatitis, dry skin, eczema, wheal and flare rash, skin hypertrophy, sweating, urticaria, vesicular rash, acanthosis, psoriasis, pustular rash, skin discoloration, conjunctivitis, ageusia, double vision, dry eyes, photophobia, tinnitus, tearing, accommodation abnormalities, blepharitis, cataract, corneal erosion, hearing loss, eye hemorrhage, glaucoma, labyrinthitis, retinal detachment, loss of taste, visual field defects, bladder pain, breast pain, cystitis, weakened urine stream, dysuria, hematuria, erectile dysfunction, kidney stones, kidney pain, menorrhagia, abnormal uterine bleeding, frequency of urination, incontinence, urgency, vaginitis, proteinuria, delayed menstrual cycle, leukorrhea, menopause, urethritis, urinary retention, vaginal bleeding, anaphylaxis, anaphylactic reaction, nightmares, short-term memory disturbances, hallucinations, coordination disorders

This medication must be stored in a tightly closed container to avoid exposure to air or moisture, maintaining a room temperature between 1 degree and 30 degrees Celsius. This will help preserve the effectiveness of the medication.

Appearance

Hard capsule with an opaque dark green upper part and pale cyan lower part containing white or yellowish powder

Package unit

28 capsules/box [14 capsules/PTP×2], 28 capsules/bottle, 100 capsules/bottle