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Drug Interactions between givinostat and zolpidem

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

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Interactions between your drugs

Moderate

zolpidem givinostat

Applies to: zolpidem and givinostat

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 (7)
  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

Drug and food interactions

Moderate

zolpidem food

Applies to: 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 (2)
  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
Moderate

givinostat food

Applies to: givinostat

ADJUST DOSING INTERVAL: Food increases the systemic exposure of givinostat. An open-label, randomized, crossover, single dose food effect study conducted in 12 healthy males used givinostat liquid filled capsules. Subjects received a single oral dose of givinostat (100 mg) in the fasting state or after a high-fat standard meal, with a washout period of at least 1 week in between. The high-fat standard meal resulted in an increase in systemic exposure (AUC) and maximum plasma concentration (Cmax) of about 40% and 23%, respectively, when compared to the fasted state. Additionally, the time to maximum concentration (Tmax) was delayed slightly from 2 to 3 hours.

MANAGEMENT: Givinostat should be administered with food to increase its absorption. In the case of the oral suspension, this can also help mask its bitter taste.

References (2)
  1. (2024) "Product Information. Duvyzat (givinostat)." ITF Therapeutics, LLC
  2. Italfarmaco Spa (2024) Center for drug evaluation and research. Application number: 217865Orig1s000. Integrated review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217865Orig1s000IntegratedR.pdf

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.

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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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