Midazolam and Zaleplon interaction

Midazolam and Zaleplon: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Midazolam (Midazolam in Sodium Chloride) label · effective 2025-07-31

Major

WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS Personnel and Equipment for Monitoring and ResuscitationOnly personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer…

Boxed warningby drug classView label on DailyMed
Major

Risks from Concomitant Use with Opioids, Other Sedative Hypnotics, or Other Central Nervous System Depressants Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Warnings and precautionsby drug classView label on DailyMed
Major

Opioid Analgesics and Other Sedative Hypnotics : Risk of respiratory depression is increased ( 7.1 )

Drug interactionsby drug classView label on DailyMed
Major

Opioid Analgesics and Other Sedative Hypnotics The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration.

Drug interactionsby drug classView label on DailyMed
Moderate

Because intravenous midazolam can depress respiration [see Clinical Pharmacology (12)] , especially when used concomitantly with opioid agonists and other sedatives [see Dosage and Administration (2)] , it should be used for sedation/anxiolysis/amnesia only in the presence of personnel skilled in early detection of hypoventilation, maintaining a patent airway,…

Warnings and precautionsby drug classView label on DailyMed

From the Zaleplon label · effective 2025-10-08

Major

The use of zaleplon with other sedative-hypnotics at bedtime or the middle of the night is not recommended (see ).

Warningsby drug classView label on DailyMed
Moderate

Post-marketing reports have shown that complex sleep behaviors may occur with zaleplon alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants.

Warningsby drug classView label on DailyMed
Moderate

Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression.

Warningsby drug classView label on DailyMed
Moderate

Dosage adjustments of zaleplon and of other concomitant CNS depressants may be necessary when zaleplon is administered with such agents because of the potentially additive effects.

Warningsby drug classView label on DailyMed
Moderate

The risk of next-day psychomotor impairment, including impaired driving, is increased if zaleplon is taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase the blood levels of zaleplon.

Warningsby drug classView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.