Names and pronunciation
(zole′pih-dem) Ambien, Ambien CR, Edluar, Sublinox , Zolpimist, Intermezzo
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Drug reference
(zole′pih-dem) Ambien, Ambien CR, Edluar, Sublinox , Zolpimist, Intermezzo
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Func. class.: Hypnotic
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Chem. class.: Imidazopyridine Controlled Substance Schedule IV
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Do not confuse: zolpidem/Zyloprim
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ACTION: Produces CNS depression at limbic, thalamic, hypothalamic levels of CNS; may be mediated by neurotransmitter γ-aminobutyric acid (GABA), not a benzodiazepine; results are sedation, hypnosis, skeletal muscle relaxation, anticonvulsant activity, anxiolytic action
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USES: Insomnia, short-term treatment
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CONTRAINDICATIONS: Hyper sensitivity to benzodiazepines Precautions: Pregnancy, breastfeeding, children <18 yr, geriatric patients, ane mia, hepatic disease, suicidal individuals, drug abuse, seizure disorders, angio edema, depression, respiratory disease, sleep apnea, myasthenia gravis, pulmo nary disease, next-morning impairments; females (lower dose needed)
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Black Box Warning: Sleep-related be- haviors (sleepwalking) Black Box Warning: Complex sleep disorders (rare): monitor for sleep eating/ driving/walking, do not use if these occur with opioids • Beers: avoid in older adults; CNS ef fects occur Black Box Warning: That complex sleep-related behaviors may occur (sleep driving/eating), to stop product if these occur • To avoid driving or other activities re quiring alertness until dosage is stabilized • To avoid alcohol ingestion • That effects may take 2 nights for benefits to be noticed; next-morning impairment may occur, to take immediately before bed • Not to use during pregnancy, breast feeding • That hangover is common in geriatric patients but less common than with barbitu rates; that rebound insomnia may occur for 1-2 nights after discontinuing product; not to discontinue abruptly; to taper, avoid use • SL: Place tablet under tongue, allow to dissolve • Not to crush, chew, break ext rel tabs • Spray: To prime spray pump before us ing (5 sprays before new use, 1 spray if not used ≥14 days), spray directly over tongue
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SIDE EFFECTS CNS: Headache, lethargy, drowsiness, daytime sedation, dizziness, confusion, light-headedness, anxiety, irritability, amnesia, poor coordination, complex sleep-related reactions (sleep driving, sleep eating), depression, somnolence, Z suicidal ideation, abnormal thinking/ behavioral changes CV: Chest pain, palpitations GI: Nausea, vomiting, diarrhea, heart burn, abdominal pain, constipation HEMA: Leukopenia, granulocytopenia (rare) MISC: Myalgia SYST: Severe allergic reactions, angio- edema, anaphylaxis
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INTERACTIONS Increase: action of both products—alco hol, CNS depressants, monitor carefully Increase or decrease: zolpidem levels— CYP3A4 inhibitors/inducers Decrease: zolpidem effect—rifamycins; avoid use Drug/Herb Increase: CNS depression—Chamomile, kava, valerian St. John’s wort: Decreased zolpidem effect, avoid use Drug/Food Food: Delayed action, absorption
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TREATMENT OF OVERDOSE: Lavage; monitor electrolytes, VS
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DOSAGE AND ROUTES Sleep-maintenance insomnia, 7-8 hours planned sleep • Adult: PO ER 6.25 mg (females) or 6.25-12.5 mg (males) immediately before bedtime with ≥7-8 hours of planned sleep before waking (max 12.5 mg); IR tablet, spray, SL (unlabeled) 5 mg (females) or 5-10 mg (males) imme diately before bedtime with ≥7-8 hours of planned sleep before waking
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Available forms: Tabs 5, 10 mg; ext rel tabs 6.25, 12.5 mg; SL: 1.75, 3.5, 5, 10 mg; oral spray 5 mg/spray
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Administer: PO route • Do not break, crush, or chew ext rel • Take with full glass of water • 1⁄2-1 hr before bedtime (PO); right before retiring (ext rel) • On empty stomach for fast onset; may be taken with food if GI symptoms occur • Store in tight container in cool envi ronment Spray route • Prime before first use (5 sprays) or if pump is not used for ≥14 days (1 spray) • Spray directly over tongue • Do not use spray with or after a meal Sublingual route • Place product under tongue; allow to dissolve before swallowing; do not take with water
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Assess: • Mental status: mood, sensorium, af- fect, memory (long, short term), excessive sedation, impaired coordination, suicidal thoughts/behaviors • Type of sleep problem: falling asleep, staying asleep • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk, may cause fetal harm; cautious use in breastfeeding
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Evaluate: • Therapeutic response: ability to sleep at night, decreased amount of early morning awakening if taking product for insomnia
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That dependence is possible after long-term use
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PHARMACOKINETICS PO: Onset up to 1.5 hr, metabolized by liver, excreted by kidneys (inactive metabolites), crosses placenta, excreted in breast milk, half-life 2-3 hr
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• Adult: PO ER 6.25 mg (females) or 6.25-12.5 mg (males) immediately before bedtime with ≥7-8 hours of planned sleep before waking (max 12.5 mg); IR tablet, spray, SL (unlabeled) 5 mg (females) or 5-10 mg (males) imme diately before bedtime with ≥7-8 hours of planned sleep before waking
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