Zolpidem

Oral
Intranasal
Sublingual
Class
Hypnotics and sedatives
Subclass
Nonbenzodiazepines
Substance name
Zolpidem tartrate
Brand names
Ambien®, Zolpimist®
Common formulations
Film-coated tablet, Oral spray
See also
Zolpidem CR (Ambien CR®)
Dosage and administration
Adults patients
Insomnia in females • Sleep-onset, short-term management
•
Start at: 5 mg PO qHS
•
Maintenance: 5-10 mg PO qHS
•
Maximum: 10 mg per day
Taken at least 7-8 hours remaining before the planned awakening. Use 5 mg in elderly patients.
Insomnia in males • Sleep-onset, short-term management
•
Start at: 5-10 mg PO qHS
•
Maintenance: 5-10 mg PO qHS
•
Maximum: 10 mg per day
Taken at least 7-8 hours remaining before the planned awakening. Use 5 mg in elderly patients.
Catatonia • Off-label
•
10 mg PO qHS
Taken at least 7-8 hours remaining before the planned awakening. Use 5 mg in elderly patients.
Idiopathic central sleep apnea • Off-label
•
10 mg PO qHS
Taken at least 7-8 hours remaining before the planned awakening. Use 5 mg in elderly patients.
Insomnia • Sleep maintenance • Off-label
•
5-10 mg PO qHS
Taken at least 7-8 hours remaining before the planned awakening. Use 5 mg in elderly patients.
Indications for use
Labeled indications
Adults
•
Treatment of insomnia in females (sleep-onset, short-term management)
•
Treatment of insomnia in males (sleep-onset, short-term management)
Off-label indications
Adults
•
Treatment of catatonia
•
Treatment of idiopathic central sleep apnea
•
Treatment of insomnia (sleep maintenance)
Safety risks
Boxed warnings
Sleepdriving, sleepwalking
•
Use extreme caution in all patients. Discontinue zolpidem immediately if a complex sleep behavior occurs.
Contraindications
Hypersensitivity to zolpidem or its components
History of complex sleep behaviors after taking zolpidem
Warnings and precautions
Anaphylaxis, anaphylactoid reactions
•
Maintain a high level of suspicion, as zolpidem has been associated with an increased risk for these adverse events.
Behavioral or personality changes, agitation, hallucinations
•
Maintain a high level of suspicion, as zolpidem has been associated with an increased risk for these adverse events.
Decreased serum zolpidem levels
•
Use caution in patients taking CYP3A4 inducers, such as rifampin or St. John's wort.
Drug withdrawal syndrome
•
Do not discontinue abruptly, as rapid dose reduction or withdrawal may cause withdrawal effects.
Increased serum zolpidem levels
•
Use caution in patients taking potent CYP3A4 inhibitors, such as ketoconazole.
Respiratory depression
•
Use caution in patients with respiratory impairment, sleep apnea or myasthenia gravis, or with concomitant use of opioids.
Somnolence
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
•
Use caution in patients taking other CNS depressants or using alcohol.
Suicidal ideation
•
Use caution in patients with depression. Monitor closely for suicidality and unusual changes in behavior.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Child-Pugh A (mild)
•
Maximal dose of 5 mg per day.
Child-Pugh B (moderate)
•
Maximal dose of 5 mg per day.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in humans. Monitor neonates for respiratory depression, withdrawal symptoms and sedation.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Dizziness, headache, somnolence
Common 1-10%
•
Agitation, nightmares, syncope, hyperhidrosis, urticaria, pallor, dysgeusia, anorexia, flatulence, vomiting, fever, tinnitus, rhinitis, cough, emotional lability, tremor, cognitive impairment, chest pain, orthostatic hypotension, dysphagia, urinary incontinence, dysuria, migraine, dysarthria, eye pain, itchy eyes, gritty eyes, red eyes, ↑ blood glucose, hypertension, pruritus, tachycardia, ↑ liver enzymes, dyspnea, cognitive impairment, disorientation, visual disturbances, falls, gastroesophageal reflux disease, lethargy, pharyngitis, menorrhagia, anxiety, arthralgia, confusion, euphoria, ataxia, hiccups, dyspepsia, asthenia, diplopia, insomnia, vertigo, depression, diarrhea, memory impairment, dry mouth, dry mouth, back pain, fatigue, hallucinations, malaise, muscle cramps, palpitations, blurred vision, skin rash, constipation, lightheadedness, myalgia, nausea, suicidal ideation, sinusitis, urinary tract infections, upper respiratory tract infections, vaginitis, hemorrhoids, restless legs syndrome, dental caries
Uncommon < 1%
•
↑ serum TBIL, ↑ serum cholesterol, myocardial infarction, pulmonary embolism, renal failure, myasthenia gravis, gout, acne vulgaris, anaphylaxis, pulmonary edema, arrhythmia, VT, angioedema, bronchospasm, ↑ BUN, phlebitis, hypotension, vesiculobullous rash, conjunctivitis, photopsia, urinary retention, anemia, lymphadenopathy, hot flashes, photosensitivity of skin, skin flushing, hypersalivation, tenesmus, weight loss, chills, hyperlacrimation, laryngitis, nosebleed, mastalgia, polyuria, urinary frequency, nocturia, yawning, ↑ appetite, ↓ libido, ↓ WBC count, belching, erectile dysfunction, ↓ SpO2
Unknown frequency
•
Hepatic encephalopathy, hip fracture, cerebrovascular events, laryngeal edema, respiratory distress, skin erythema, oral ulcers, sleepwalking, abdominal pain, jaundice, paresthesia, sleepdriving, behavioral or personality changes, tongue paresthesia, oral mucosal erythema
Interactions
Drug(s)
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