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7 Interactions found for:

Ambien and Cymbalta
Interactions Summary
  • 4 Major
  • 3 Moderate
  • 0 Minor
  • Ambien
  • Cymbalta

Drug Interactions

Moderate
Ambien + Cymbalta

The following applies to the ingredients: Zolpidem (found in Ambien) and Duloxetine (found in Cymbalta)

Using zolpidem together with DULoxetine may increase side effects such as dizziness, drowsiness, confusion, and difficulty concentrating. Some people, especially the elderly, may also experience impairment in thinking, judgment, and motor coordination. You should avoid or limit the use of alcohol while being treated with these medications. Also avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medications affect you. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Drug and Food Interactions

Moderate
Ambien + Food

The following applies to the ingredients: Zolpidem (found in Ambien)

You should avoid the use of alcohol while being treated with zolpidem. Alcohol can increase the nervous system side effects of zolpidem such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment. Taking zolpidem with food may delay the onset of sleep. For faster sleep onset, zolpidem should not be taken with or immediately after a meal. This will make it easier for your body to absorb the medication. Talk to your doctor or pharmacist if you have any questions or concerns.

Moderate
Cymbalta + Food

The following applies to the ingredients: Duloxetine (found in Cymbalta)

DULoxetine may cause liver damage, and taking it with alcohol may increase that risk. You should avoid or limit the use of alcohol while being treated with DULoxetine. Call your doctor immediately if you have fever, chills, joint pain or swelling, excessive tiredness or weakness, unusual bleeding or bruising, skin rash or itching, loss of appetite, nausea, vomiting, dark colored urine, or yellowing of the skin or the whites of your eyes, as these may be symptoms of liver damage. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Drug and Pregnancy Interactions

The following applies to the ingredients: Zolpidem (found in Ambien)

Professional Content

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: The data do not report a clear association between use of this drug and major birth defects.

Comments:
-A syndrome of hypothermia, hypotonia, respiratory depression and difficulty feeding may occur in in infants of mothers administered this drug in the late phase of pregnancy or during childbirth.
-Withdrawal symptoms may occur in neonates whose mothers were taking sedative-hypnotics late in pregnancy.

Cases of severe neonatal respiratory depression have been reported when this drug was used at the end of pregnancy, especially when used with other central nervous system (CNS) depressants. Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may be at risk for developing physical dependence and withdrawal symptoms in the postnatal period. Additionally, neonatal flaccidity also has been reported in infants born to mothers who received sedative/hypnotic drugs during pregnancy.

Animal studies have revealed no evidence of teratogenicity or fertility impairment, but adverse effects including incomplete fetal skeletal ossification and increased embryo-fetal death.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

References

  1. "Product Information. Ambien (zolpidem)." sanofi-aventis PROD (2001):
  2. "Product Information. Ambien CR (zolpidem)." Sanofi-Synthelabo Inc (2005):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals (2009):
  6. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm" (2010):
  7. "Product Information. Intermezzo (zolpidem)." Purdue Pharma LP (2011):
  8. "Product Information. Zolpimist (zolpidem)." Magna Pharmaceuticals Inc (2017):

The following applies to the ingredients: Duloxetine (found in Cymbalta)

Professional Content

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: Observational study data have not produced clear drug-associated risks regarding adverse events or major birth defects.

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to this drug late in the third trimester may require respiratory support, tube feeding, and/or prolonged hospitalization.
-Exposed neonates should be monitored after delivery for direct toxic effects of this drug, drug discontinuation syndrome, and serotonin syndrome.
-Women who discontinued antidepressant use during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant use.

Animal studies have revealed increased perinatal toxicity and fetotoxicity at doses potentially correlated with maternal toxicity. There are no controlled data in human pregnancy.

Some neonates exposed to SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors) late in the third trimester had clinical findings including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. This clinical picture is consistent with either direct toxic effect of SSRIs and SNRIs, drug discontinuation syndrome, or serotonin syndrome.

A less than 2-fold increase in postpartum hemorrhage was determined by observational data in patients exposed to the drug within 1 month before birth.

A study of women with a history of major depression who were euthymic at the beginning of pregnancy, showed women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

Healthcare providers are encouraged to register patients receiving Cymbalta by calling the Cymbalta Pregnancy Registry at 1-866-814-6975 or by visiting www.cymbaltapregnancyregistry.com.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

References

  1. "Product Information. Cymbalta (duloxetine)." Lilly, Eli and Company (2004):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Drug and Breastfeeding Interactions

The following applies to the ingredients: Zolpidem (found in Ambien)

Professional Content

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Some experts state that this drug should be used with caution.
-Due to the low levels of this drug in breastmilk and its short half-life, amounts ingested by nursing infants are small and would not be expected to cause any adverse effects in these infants.
-The American Academy of Pediatrics considers this drug to be compatible with breastfeeding.
-Some experts recommend monitoring breastfed infants for hypotonia, respiratory depression, and sedation.

After a single, 20 mg oral dose was administered to 5 nursing mothers (who were 3 to 4 days postpartum), breastmilk collected at 3 hours contained between 0.004% to 0.019% of the maternal dosage; the drug was undetectable (drug levels less than 0.5 mcg/L) in the breastmilk 13 to 16 hours after the dose was given.

In animal models, administration of this drug during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose tested.

References

  1. "Product Information. Ambien (zolpidem)." sanofi-aventis PROD (2001):
  2. "Product Information. Ambien CR (zolpidem)." Sanofi-Synthelabo Inc (2005):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals (2009):
  6. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm" (2010):
  7. "Product Information. Intermezzo (zolpidem)." Purdue Pharma LP (2011):
  8. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
  9. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health (2015):
  10. "Product Information. Zolpimist (zolpidem)." Magna Pharmaceuticals Inc (2017):

The following applies to the ingredients: Duloxetine (found in Cymbalta)

Professional Content

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Some experts state that a more thoroughly studied alternative agent (e.g., nortriptyline, paroxetine, sertraline) may be preferred while breastfeeding premature or neonates.
-The American Academy of Pediatrics classifies other antidepressants as agents for which the effect on nursing infants is unknown but may be of concern.
-Exposed infants should be monitored for developmental milestones, feeding, sedation, weight gain, especially in younger infants who are exclusively breastfed and/or when breastfed infants are exposed to multiple antipsychotropic agents.

The estimated neonatal dose is approximately 0.1% to 0.3% of the maternal dose.

References

  1. "Product Information. Cymbalta (duloxetine)." Lilly, Eli and Company (2004):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
  5. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health (2015):
  6. National Library of Medicine (US) "Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK501922/" (2019):

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.

Switch to: Professional Interactions

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.

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