No black box warning on record for Zolpidem

As of the latest FDA labeling reviewed, Zolpidem (zolpidem tartrate) does not carry a black box warning. Standard warnings and precautions still apply — see the full Zolpidem medicine page for the complete safety profile.

Other warnings & precautions

Complex Sleep Behaviors (Boxed Warning): Zolpidem can cause complex sleep behaviors including sleepwalking, sleep-driving, and other activities while not fully awake. These behaviors can result in serious injuries or death. Discontinue immediately if a complex sleep behavior occurs. Concurrent alcohol and other CNS depressants increase this risk.
Next-Morning Impairment: Blood levels of zolpidem in some patients are still high enough the morning after use to cause impairment — including driving impairment. This is why the FDA lowered the dose in 2013. Do not drive or operate heavy machinery the day after taking zolpidem, especially extended-release formulations. Women are more susceptible (lower metabolism).
Dependence and Rebound: Tolerance and dependence can develop within 2 weeks of regular use. Abrupt discontinuation can cause rebound insomnia and withdrawal. Use only as needed, not every night. Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment.
Respiratory Depression: Use with extreme caution in patients with compromised respiratory function (COPD, sleep apnea). Avoid in patients with untreated obstructive sleep apnea.

No black box warning on record for Zolpidem

Other warnings & precautions

Complex Sleep Behaviors (Boxed Warning): Zolpidem can cause complex sleep behaviors including sleepwalking, sleep-driving, and other activities while not fully awake. These behaviors can result in serious injuries or death. Discontinue immediately if a complex sleep behavior occurs. Concurrent alcohol and other CNS depressants increase this risk.
Next-Morning Impairment: Blood levels of zolpidem in some patients are still high enough the morning after use to cause impairment — including driving impairment. This is why the FDA lowered the dose in 2013. Do not drive or operate heavy machinery the day after taking zolpidem, especially extended-release formulations. Women are more susceptible (lower metabolism).
Dependence and Rebound: Tolerance and dependence can develop within 2 weeks of regular use. Abrupt discontinuation can cause rebound insomnia and withdrawal. Use only as needed, not every night. Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment.
Respiratory Depression: Use with extreme caution in patients with compromised respiratory function (COPD, sleep apnea). Avoid in patients with untreated obstructive sleep apnea.

Zolpidem Black Box Warning

No black box warning on record for Zolpidem

Other warnings & precautions

Zolpidem Black Box Warning

No black box warning on record for Zolpidem

Other warnings & precautions