Stilnox

Zolpidem tartrate

Short-term treatment of severe sleep disorders in adults w/ transient insomnia or short-term insomnia.

Treatment duration: 2-5 days for transient insomnia; 2-3 wk for short-term insomnia. Do not exceed 4 wk, including tapering-off period. Adult 10 mg single dose taken immediately at bedtime. Max dose: 10 mg. Elderly or debilitated patient 5 mg (½ tab). Patient w/ liver failure Initially 5 mg daily. Max dose: 10 mg.

May be taken with or without food.

Hypersensitivity. Patients w/ severe resp failure; sleep apnea syndrome; severe, acute or chronic liver failure; history of complex sleep patterns after zolpidem use; myasthenia.

Not recommended for long-term use due to risk of tolerance, abuse & physical or psychological dependence. Use w/ extreme caution in patients w/ current or history of alcohol or drug abuse. Risk of w/drawal syndrome & rebound effect. Possible discomfort during tapering-off period. Psychomotor impairment & anterograde amnesia may occur w/in hr of administration. Benzodiazepines & related drugs may cause a syndrome combining varying degrees of impaired consciousness w/ behavioral & memory disorders. Immediately stop treatment if patient exhibits complex sleep behaviour; somnambulism & associated behavior. Risk of accumulation. Elimination t_½ may be considerably longer in elderly & patients w/ kidney or liver failure. Concomitant use w/ other opioids can cause sedation, resp depression, coma & death. Do not rechallenge in patients who develop angioedema involving the tongue, glottis or larynx after treatment. Reports of increased incidence of suicidal ideation, suicide attempts & suicide in patients w/ or w/o depression. Caution in patients w/ resp failure; elderly; women of child-bearing potential. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose & galactose malabsorption should not take this medicine. Major influence on the ability to drive & use machines. Do not drink alcohol or take other psychoactive substances during treatment. Not recommended during pregnancy & lactation. Not recommended in paed population.

Hallucinations, agitation, nightmares, depression; impaired alertness or drowsiness (particularly in the elderly), headache, vertigo, insomnia, cognitive disorders (eg, anterograde amnesia); diarrhea, nausea, vomiting, abdominal pain; upper & lower resp tract infections; asthenia.

Additive CNS depressant effects w/ morphine derivatives (analgesic agents, antitussive agents & replacement therapies), neuroleptic agents, barbiturates, benzodiazepines, anxiolytic agents other than benzodiazepines (eg, meprobamate), hypnotic agents, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H₁-antihistamines, centrally-acting antihypertensive agents, baclofen, thalidomide, antiepileptic drugs & anesth; alcohol; opioids. Increased blood levels w/ fluvoxamine; ciprofloxacin. Decreased blood levels w/ St. John's wort. Decreased plasma conc w/ rifampicin. Increased next-day drowsiness & psychomotor impairment w/ other CNS depressants. Reports of visual hallucinations w/ antidepressants including bupropion, fluoxetine, sertraline & venlafaxine. Increased risk of potentially fatal resp depression w/ buprenorphine as replacement therapy; barbiturates. Increased risk of collapse w/ resp &/or cardiac arrest w/ clozapine. Mildly increased sedative effects w/ clarithromycin, erythromycin, telithromycin; ketoconazole, itraconazole, voriconazole; nelfinavir, ritonavir-boosted PIs.

Hypnotics & Sedatives

N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.

P₁S₁S₃