Zolpidem

DEA Class;  Rx

Common Brand Names; Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist

Contraindicated in patients with known hypersensitivity to zolpidem; observed reactions include anaphylaxis and angioedema

Patients who have experienced complex sleep behaviors after receiving therapy

• Dizziness (5-12%)
• Headache (7-19%)
• Drowsiness (6-15%)
• Allergy (4%)
• Hallucinations (4%)
• Myalgia (4%)
• Sinusitis (4%)
• Memory disorder (3%)
• Visual disturbance (3%)
• Pharyngitis (3%)
• Lightheadedness (2%)
• Palpitation (2%)
• Rash (2%)
• Constipation (2%)
• Depression (2%)
• Drowsiness (2%)
• Asthenia (1%)
• Diarrhea (1%)
• Dry mouth (1%)
• Flu-like symptoms (1%)

The risk of next-day psychomotor impairment, including impaired driving, is increased if taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if co-administered with other CNS depressants or alcohol; or if co-administered with other drugs that increase blood levels of zolpidem; patients should be warned against driving and other activities requiring complete mental alertness if drug taken in these circumstances

Co-administration with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression; dosage adjustments of zolpidem and of other concomitant CNS depressants may be necessary when zolpidem is administered with such agents because of the potentially additive effects; the use of zolpidem with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended

Postmarketing reports of respiratory insufficiency in patients receiving 10 mg dose, most of whom had preexisting respiratory impairment, reported; risk of respiratory depression should be considered prior to prescribing this drug in patients with respiratory impairment including sleep apnea and myasthenia gravis or with concomitant opioid use

Neonates born to mothers using zolpidem late in the third trimester of pregnancy reported to experience symptoms of respiratory depression and sedation; published data on use of zolpidem during pregnancy have not reported clear association with zolpidem and major birth defects

Limited data report presence of zolpidem in human milk; there are reports of excess sedation in infants exposed to zolpidem through breastmilk; there is no information on effects on milk production