See also:
What is the most important information I should know about Unisom SleepTabs?
OTC labeling: Do not use in children <12 years of age.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to Unisom SleepTabs or any component of the formulation; narrow angle glaucoma; asthmatic attack; prostatic hypertrophy; stenosing peptic ulcer, pyloroduodenal obstruction; bladder-neck obstruction; concurrent use with monoamine oxidase-inhibitors.
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What are the possible side effects of Unisom SleepTabs?
Undesirable effects reported for captopril and/or ACE inhibitor include:
Blood and lymphatic disorders:
Very Rare: neutropenia/agranulocytosis, pancytopenia particularly in patients with renal dysfunction, anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto-immune diseases and/or positive ANA-titres.
Metabolism and nutrition disorders:
Rare: Anorexia
Very Rare: Hyperkalaemia, hypoglycaemia
Psychiatric disorders:
Common: Sleep disorders.
Very Rare: Confusion, depression.
Nervous system disorders:
Common: Taste impairment, dizziness.
Rare: Drowsiness, headache and paraesthesia.
Very Rare: Cerebrovascular incidents, including stroke, and syncope.
Eye disorders:
Very Rare: Blurred vision.
Cardiac disorders:
Uncommon: Tachycardia or tachyarrhythmia, angina pectoris, palpitations.
Very Rare: Cardiac arrest, cardiogenic shock.
Vascular disorders
Uncommon: Hypotension, Raynaud syndrome, flush, pallor.
Respiratory, thoracic and mediastinal disorders:
Common: Dry, irritating (non productive) cough and dyspnoea.
Very Rare: Bronchospasm, rhinitis, allergic alveolitis / eosinophilic pneumonia.
Gastrointestinal disorders:
Common: Nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth.
Rare: Stomatitis/aphthous ulcerations.
Very Rare: Glossitis, peptic ulcer, pancreatitis.
Hepato-biliary disorders:
Very Rare: Impaired hepatic function and cholestasis. (including jaundice), hepatitis including necrosis, elevated liver enzymes and bilirubin.
Skin and subcutaneous tissue disorders:
Common: Pruritus with or without a rash, rash and alopecia.
Uncommon: Angioedema
Very Rare: Urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions and exfoliative dermatitis.
Musculoskeletal, connective tissue and bone disorders:
Very rare: Myalgia, arthralgia.
Renal and urinary disorders:
Rare: Renal function disorders including renal failure, polyuria, oliguria, increased urine frequency.
Very Rare: Nephrotic syndrome.
Reproductive system and breast disorders:
Very Rare: Impotence, gynaecomastia.
General disorders:
Uncommon: Chest pain, fatigue, malaise.
Very Rare: Fever
Investigations:
Very Rare: Proteinuria, eosinophilia, increase of serum potassium, decrease of serum sodium, elevation of BUN, serum creatinine and serum bilirubin, decreases in haemoglobin, haematocrit, leucocytes, thrombocytes, positive ANAtitre, elevated ESR.
Intestinal angioedema has also been reported very rarely in patients with ACE inhibitors and should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Hypertension: this medicine is indicated for the treatment of hypertension.
Heart Failure:
this medicine is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and when appropriate, digitalis and beta-blockers.
Myocardial Infarction:
-Short -term (4 weeks) treatment: this medicine is indicated in any clinically stable patients within the first 24 hours of an infarction.
-Long term prevention of symptomatic heart failure: this medicine is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction <40%).
Type I Diabetic Nephropathy:
this medicine is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes..
Unisom SleepTabs is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Antihistamines can cause drowsiness and are sometimes used a sleep aids.
Unisom SleepTabs is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.
Unisom SleepTabs is also used as a short-term treatment for sleep problems (insomnia).
Unisom SleepTabs may also be used for purposes not listed in this medication guide.
Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Unisom SleepTabs has also been administered in veterinary applications and was formerly used in parkinsonism. [PubChem]
Use Unisom SleepTabs chewable tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Unisom SleepTabs chewable tablets.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsInsomnia: Reduce difficulty falling asleep
Off Label UsesNausea and vomiting of pregnancy
Unisom SleepTabs is usually given in combination with pyridoxine for the treatment of nausea and vomiting of pregnancy. Data from a randomized placebo-controlled trial supports the use of Unisom SleepTabs and pyridoxine (Diclectin) in the treatment of nausea and vomiting of pregnancy.
Unisom SleepTabs 5 mg oral tablet, chewable:
10 mg orally every 4 to 6 hours not to exceed 6 doses daily.
Usual Adult Dose for Allergic Conjunctivitis
Unisom SleepTabs 5 mg oral tablet, chewable:
10 mg orally every 4 to 6 hours not to exceed 6 doses daily.
Usual Adult Dose for Insomnia
12 years of age and older: 25 mg orally 30 minutes before bed
Maximum dose: Take once daily or as directed by physician
Comments: Do not use 25 mg Unisom SleepTabs in children under 12 years of age
Usual Pediatric Dose for Allergic Rhinitis
Unisom SleepTabs 5 mg oral tablet, chewable:
12 years or older: 10 mg orally every 4 to 6 hours not to exceed 6 doses daily
6 years to under 12 years: 5 mg orally every 4 to 6 hours not to exceed 6 doses daily
Usual Pediatric Dose for Allergic Conjunctivitis
Unisom SleepTabs 5 mg oral tablet, chewable:
12 years or older: 10 mg orally every 4 to 6 hours not to exceed 6 doses daily
6 years to under 12 years: 5 mg orally every 4 to 6 hours not to exceed 6 doses daily
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dialysis
Data not available
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What other drugs will affect Unisom SleepTabs?
The simultaneous use of Unisom SleepTabs with psychotropic, anticonvulsant medications and ethanol is observed enhancement inhibitory action alprazolam on the CNS.
The simultaneous use with blockers of histamine H2-receptor reduce the clearance of alprazolam and increase the inhibitory effect of alprazolam on the CNS; macrolide antibiotics reduce the clearance of alprazolam.
The simultaneous use with hormonal oral contraceptives increased T1/2 of alprazolam.
Simultaneous administration of Unisom SleepTabs with dextropropoxyphene observed a more pronounced CNS depression than in combination with other benzodiazepines, as may increase the concentration of alprazolam in blood plasma.
Simultaneous treatment with digoxin increases the risk of intoxication by cardiac glycosides.
Alprazolam increases the concentration of imipramine in plasma.
Simultaneous administration with itraconazole, ketoconazole increases the effects of alprazolam.
Simultaneous administration with paroxetine may increases the effects of alprazolam due to the inhibition of its metabolism.
Fluvoxamine increases the concentration of alprazolam in plasma and risk of its side effects.
Simultaneous administration of Unisom SleepTabs with fluoxetine may increase the concentration of alprazolam in plasma by decreasing its metabolism and clearance under the influence of fluoxetine which is accompanied by psychomotor disorders.
It can not be exclude the possibility of strengthening effect of alprazolam for simultaneous administration with erythromycin.
