Skip to Content

Temazepam Pregnancy and Breastfeeding Warnings

Temazepam is also known as: Restoril

Temazepam Pregnancy Warnings

AU, UK: Use is not recommended. US: Use is contraindicated. AU TGA pregnancy category: C US FDA pregnancy category: X Comments: -The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms. -Benzodiazepines may cause fetal harm when administered during pregnancy. -The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.

Several studies have suggested an increased risk of congenital malformations associated with the use of benzodiazepines during the first trimester of pregnancy. There are no adequate studies in pregnant women. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Temazepam Breastfeeding Warnings

AU, US: Caution is recommended. UK: Use is contraindicated. Excreted into human milk: Yes Comments: This drug may cause drowsiness and feeding difficulties in the infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Restoril (temazepam)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Restoril (temazepam)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.