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Drug Interactions between Intermezzo and Leader Heartburn Relief

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

cimetidine zolpidem

Applies to: Leader Heartburn Relief (cimetidine) and Intermezzo (zolpidem)

MONITOR: Coadministration with inhibitors of CYP450 3A4 may increase the plasma concentrations of zolpidem, which is partially metabolized by the isoenzyme. When a single 5 mg dose of zolpidem was administered to 12 healthy study subjects following treatment with the potent CYP450 3A4 inhibitor ketoconazole (200 mg twice daily for 2 days), zolpidem peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 35% and 67%, respectively. Increased sedation and other pharmacodynamic effects were noted.

MANAGEMENT: Caution is advised when zolpidem is used with CYP450 3A4 inhibitors. Patients should be advised to avoid driving, operating machinery, or engaging in potentially hazardous activities requiring mental alertness and motor coordination until they know how the medications affect them, and to notify their physician if they experience excessive somnolence or dizziness.

References

  1. (2001) "Product Information. Ambien (zolpidem)." sanofi-aventis
  2. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical
  3. Luurila H, Kivisto KT, Neuvonen PJ (1998) "Effect of itraconazole on the pharmacokinetics and pharmacodynamics of zolpidem." Eur J Clin Pharmacol, 54, p. 163-6
  4. Greenblatt DJ, vonMoltke LL, Harmatz JS, Mertzanis P, Graf JA, Durol ALB, Counihan M, RothSchechter B, Shader RI (1998) "Kinetic and dynamic interaction study of zolpidem with ketoconazole, itraconazole, and fluconazole." Clin Pharmacol Ther, 64, p. 661-71
  5. Greenblatt DJ, von Moltke LL, Harmatz JS, et al. (2000) "Differential impairment of triazolam and zolpidem clearance by ritonavir." J Acquir Immune Defic Syndr, 24, p. 129-36
  6. Saari TI, Laine K, Leino K, Valtonen M, Neuvonen PJ, Olkkola KT (2007) "Effect of voriconazole on the pharmacokinetics and pharmacodynamics of zolpidem in healthy subjects." Br J Clin Pharmacol, 63, p. 116-20
  7. Farkas D, Volak L, Harmatz J, von Moltke L, Court M, Greenblatt D (2009) "Short-term clarithromycin administration impairs clearance and enhances pharmacodynamic effects of trazodone but not of zolpidem." Clin Pharmacol Ther, 85, p. 644-50
View all 7 references

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Drug and food interactions

Moderate

zolpidem food

Applies to: Intermezzo (zolpidem)

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of zolpidem. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

ADJUST DOSING INTERVAL: Administration of zolpidem with food may delay the onset of hypnotic effects. In 30 healthy subjects, administration of zolpidem 20 minutes after a meal resulted in decreased mean peak plasma drug concentration (Cmax) and area under the concentration-time curve (AUC) by 25% and 15%, respectively, compared to fasting. The time to reach peak plasma drug concentration (Tmax) was prolonged by 60%, from 1.4 to 2.2 hours.

MANAGEMENT: Patients receiving zolpidem should be advised to avoid the consumption of alcohol. For faster sleep onset, zolpidem should not be administered with or immediately after a meal.

References

  1. (2001) "Product Information. Ambien (zolpidem)." sanofi-aventis
  2. Yamreudeewong W, Henann NE, Fazio A, Lower DL, Cassidy TG (1995) "Drug-food interactions in clinical practice." J Fam Pract, 40, p. 376-84

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Minor

cimetidine food

Applies to: Leader Heartburn Relief (cimetidine)

Concurrent use of cimetidine and ethanol may result in increased ethanol concentrations. The mechanism appears to be due to inhibition of gastric alcohol dehydrogenase by cimetidine, leading to increased bioavailability of the alcohol and inhibition of hepatic metabolism of alcohol. The clinical significance of this interaction is limited. More importantly, patients requiring cimetidine for gastrointestinal disease should be counseled to avoid alcohol to prevent worsening of their disease. The other H-2 receptor antagonists appear to have minimal effects on the concentrations of alcohol.

References

  1. Feely J, Wood AJ (1982) "Effects of cimetidine on the elimination and actions of ethanol." JAMA, 247, p. 2819-21
  2. Hansten PD (1992) "Effects of H2-receptor antagonists on blood alcohol levels." JAMA, 267, p. 2469

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Minor

cimetidine food

Applies to: Leader Heartburn Relief (cimetidine)

Caffeine effects may be increased in patients also taking cimetidine. The mechanism may be due to decreased caffeine metabolism induced by cimetidine. Although adequate clinical data are lacking, a reduction in dose or elimination of caffeine may be needed if excess CNS stimulation is observed.

References

  1. (2001) "Product Information. Tagamet (cimetidine)." SmithKline Beecham
  2. Broughton LJ, Rodgers HJ (1981) "Decreased systenuc clearance of caffeine due to cimetidine." Br J Clin Pharmacol, 12, p. 155-9

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Minor

cimetidine food

Applies to: Leader Heartburn Relief (cimetidine)

H2 antagonists may reduce the clearance of nicotine. Cimetidine, 600 mg given twice a day for two days, reduced clearance of an intravenous nicotine dose by 30%. Ranitidine, 300 mg given twice a day for two days, reduced clearance by 10%. The clinical significance of this interaction is not known. Patients should be monitored for increased nicotine effects when using the patches or gum for smoking cessation and dosage adjustments should be made as appropriate.

References

  1. Bendayan R, Sullivan JT, Shaw C, Frecker RC, Sellers EM (1990) "Effect of cimetidine and ranitidine on the hepatic and renal elimination of nicotine in humans." Eur J Clin Pharmacol, 38, p. 165-9

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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