Zoldem

Zoldem

zolpidem

Manufacturer:

Medichem

Distributor:

United Lab
Concise Prescribing Info
Contents
Zolpidem tartrate
Indications/Uses
Hypnotic in short-term treatment of insomnia characterized by difficulties w/ sleep initiation.
Dosage/Direction for Use
Adult <65 yr Initially 5 mg (female) & 5 or 10 mg (male) once daily. Max: 10 mg once daily. Elderly & debilitated 5 mg (½ tab) once daily. Hepatic impairment Start at 5 mg once daily. All doses to be given immediately before bedtime. Should not exceed 4 wk.
Administration
Should be taken on an empty stomach: Do not take w/ or immediately after a meal.
Contraindications
Hypersensitivity. Obstructive sleep apnea, myasthenia gravis, severe hepatic insufficiency, acute &/or severe resp depression. History of abuse of drugs, alcohol or other substances.
Special Precautions
Patients w/ compromised resp function or resp impairment including sleep apnea & myasthenia gravis. Patients w/ history of addiction to or abuse of drugs or alcohol &/or concomitant psychiatric illness. Evaluate for co-morbid diagnosis before initiation. May develop tolerance; induce anterograde amnesia. Avoid abrupt withdrawal. Discontinue use if angioedema develops; if "sleep-driving" episode occurs & during abnormal thinking & behavioral changes; if psychiatric & "paradoxical" reaction occurs. Concomitant use of CNS depressants (eg, benzodiazepines, opioids, TCAs, alcohol). May impair ability to drive or other activities requiring complete mental alertness. Depressed patients. Not to be used during pregnancy. Not recommended during lactation. Not to be used in childn <18 yr. Elderly.
Adverse Reactions
Falls, allergy, allergic reaction, aggravated allergy, anaphylactic shock, edema, face/angioneurotic edema, back pain, flu-like symptoms, pain, chest pain, pallor, asthenia, fatigue, fever, malaise, trauma, hot flashes, rigors, increased tolerance, infection, abscess herpes simplex/zoster; palpitation, postural hypotension, hypotension, syncope, flushing, cerebrovascular disorder, HTN, tachycardia, angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, aggravated HTN, MI, phlebitis, pulmonary embolism/edema, varicose veins, ventricular tachycardia; impotence, decreased wt, increased appetite, decreased libido, hyperglycemia, thirst, gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase/BUN, periorbital edema; diarrhea, dry mouth, abdominal pain, constipation, altered/increased saliva, tenesmus, dyspepsia, hiccup, anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting, enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries; abnormal hepatic function, increased AST/ALT, bilirubinemia; increased erythrocyte sedimentation rate, anemia, hyperhemoglobinemia, leucopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis; arthralgia, myalgia, arthritis, arthrosis, muscle weakness, sciatica, tendinitis; daytime drowsiness, drowsiness, dizziness, vertigo, amnesia, nausea, headache, feeling drugged, lethargy, lightheadedness, depression, irritability, restlessness, nightmare, sleep disorder, ataxia, confusion, euphoria, insomnia, agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor, abnormal gait, abnormal thinking & behavior changes, aggressive reaction, apathy, anger, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, psychosis, suicide attempts, tetany, yawning; menstrual disorder, vaginitis, breast fibroadenosis/neoplasm/pain, UTI, cystitis, urinary incontinence, acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention; sinusitis, pharyngitis, upper resp infection, lower resp infection, bronchitis, coughing, dyspnea, rhinitis, bronchospasm, resp depression, epistaxis, hypoxia, laryngitis, pneumonia; rash, increased sweating, flushing, pruritus, acne, bullous eruption, dermatitis, furunculosis, photosensitivity reaction, urticaria; abnormal accommodation, glaucoma, diplopia, abnormal vision, eye irritation/pain, scleritis, conjunctivitis, corneal ulceration, abnormal lacrimation, parosmia, photopsia, taste perversion, tinnitus, otitis externa/media.
Drug Interactions
Enhanced sedative effects w/ alcohol & ketoconazole. Additive effect in decreased alertness w/ imipramine, chlorpromazine. Additive effect in psychomotor performance w/ fluoxetine. Increased drowsiness w/ sertraline. Reduced effects & plasma conc w/ rifampicin. Increased AUC by itraconazole.
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Presentation/Packing
Form
Zoldem FC tab 10 mg
Packing/Price
30's (P1,830/pack, P61/film-coated tab)
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