Zolpidem - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS CNS-Depressant Effects: Impaired alertness and motor coordination, including risk of morning impairment.

Risk increases with dose and use with other CNS depressants and alcohol.

Caution patients against driving and other activities requiring complete mental alertness the morning after use.

Instruct patients on correct use.

Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use.

Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported.

Do not rechallenge if such reactions occur.

Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported.

Immediately evaluate any new onset behavioral changes.

Depression: Worsening of depression or suicidal thinking may occur.

Prescribe the least amount of tablets feasible to avoid intentional overdose.

Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function.

Hepatic Impairment: Avoid Zolpidem tartrate extended-release tablets use in patients with severe hepatic impairment.

Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation. ( 5.9 , 9.3 ) 5.1 Complex Sleep Behaviors Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of zolpidem tartrate extended-release tablets.

Patients can be seriously injured or injure others during complex sleep behaviors.

Such injuries may result in a fatal outcome.

Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported.

Patients usually do not remember these events.

Postmarketing reports have shown that complex sleep behaviors may occur with zolpidem tartrate extended-release tablets alone at recommended doses, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interactions ] .

Discontinue Zolpidem tartrate extended-release tablets immediately if a patient experiences a complex sleep behavior [see Contraindications ] .

5.2 CNS-Depressant Effects and Next-Day Impairment Zolpidem tartrate extended-release tablets are a CNS depressant and can impair daytime function in some patients even when used as prescribed.

Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of subjective symptoms, and may not be reliably detected by ordinary clinical exam (i.e. less than formal psychomotor testing).

While pharmacodynamic tolerance or adaptation to some adverse depressant effects of zolpidem tartrate extended-release tablets may develop, patients using zolpidem tartrate extended-release tablets should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use.

Additive effects occur with concomitant use of other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use [see Drug Interactions ].

Downward dose adjustment of zolpidem tartrate extended-release tablets and concomitant CNS depressants should be considered [see Dosage and Administration ] .