What are the contraindications for prescribing Ambien (zolpidem) to an adult patient with a history of sleepwalking and insomnia?

Contraindications for Ambien (Zolpidem)

Ambien (zolpidem) is absolutely contraindicated in patients with a history of complex sleep behaviors (including sleepwalking) on zolpidem or any sleep medication, and in those with known hypersensitivity to zolpidem. 1

Absolute Contraindications

Complex Sleep Behaviors - Most Critical for This Patient

• The FDA explicitly contraindicates zolpidem in patients who have experienced complex sleep behaviors after taking zolpidem, including sleepwalking, sleep-driving, and engaging in other activities while not fully awake. 1
• Complex sleep behaviors can occur after the first dose or any subsequent use, and patients with a history of sleepwalking are at particularly high risk. 1, 2
• These behaviors may result in serious injuries or death, and the FDA has issued a black box warning specifically about this risk. 1
• For your patient with a history of sleepwalking, zolpidem should never be prescribed. 1

Hypersensitivity Reactions

• Zolpidem is contraindicated in patients with known hypersensitivity to zolpidem, including those who have experienced anaphylaxis or angioedema. 1
• Cases of angioedema involving the tongue, glottis, or larynx have been reported after first or subsequent doses. 1

Critical Safety Warnings Beyond Absolute Contraindications

High-Risk Situations Requiring Extreme Caution or Avoidance

Concurrent CNS Depressants:

• Coadministration with benzodiazepines, opioids, tricyclic antidepressants, or alcohol significantly increases CNS depression risk and should be avoided. 1
• The use of zolpidem with other sedative-hypnotics at bedtime is not recommended. 1

Inadequate Sleep Time:

• Zolpidem should never be taken with less than 7-8 hours of sleep time remaining, as this dramatically increases next-day psychomotor impairment and driving risk. 1

Pregnancy:

• The FDA classifies zolpidem as category C based on adverse fetal outcomes in animal studies. 3
• Maternal exposure increases risk of low birth weight (OR 1.39), preterm delivery (OR 1.49), small for gestational age babies (OR 1.34), and cesarean deliveries (OR 1.74). 3

Special Population Considerations

Women:

• Women clear zolpidem 45% slower than men, resulting in higher blood levels and greater next-day impairment risk. 4
• The FDA mandates lower doses for women (5 mg immediate-release, 6.25 mg extended-release) due to this pharmacokinetic difference. 4

Elderly Patients:

• Elderly patients are at higher risk of falls, cognitive impairment, and complex sleep behaviors. 1, 3
• Maximum dose should be 5 mg regardless of sex due to increased sensitivity. 4

Hepatic Impairment:

• Patients with severe hepatic impairment require dose reduction to 5 mg due to impaired drug clearance. 4

Common Pitfalls to Avoid

• Prescribing zolpidem to patients with any history of sleepwalking or complex sleep behaviors—this is the most critical error and represents an absolute contraindication. 1, 2
• Prescribing 10 mg doses to women despite FDA warnings—approximately 50% of female patients continued receiving high doses even after the 2013 FDA mandate. 4
• Failing to discontinue zolpidem immediately if complex sleep behaviors occur—continuation after such events is contraindicated. 1
• Combining zolpidem with alcohol or other CNS depressants, which significantly increases adverse event risk. 1

Alternative Treatment for This Patient

Since zolpidem is contraindicated in your patient with sleepwalking history, the American Academy of Sleep Medicine recommends:

• Cognitive Behavioral Therapy for Insomnia (CBT-I) as first-line treatment. 5, 6
• If pharmacotherapy is necessary, consider ramelteon 8 mg (no complex sleep behavior risk), low-dose doxepin 3-6 mg (minimal side effects), or suvorexant (different mechanism of action). 5, 6
• Avoid all benzodiazepine receptor agonists (zolpidem, eszopiclone, zaleplon) in patients with sleepwalking history. 2, 7