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Hetlioz

Generic Name: tasimelteon (TAS-i-MEL-tee-on)
Brand Name: Hetlioz

Hetlioz is used for:

Treating a certain type of sleep problem called Non-24-Hour Sleep-Wake Disorder (Non-24).

Hetlioz is a melatonin agonist. Exactly how it works is not known. It acts on the melatonin receptors in the brain to help regulate the body's sleep cycle.

Do NOT use Hetlioz if:

  • you are allergic to any ingredient in Hetlioz
  • you have severe liver problems
  • you are taking fluvoxamine or rifampin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hetlioz:

Some medical conditions may interact with Hetlioz. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems
  • if you smoke

Some MEDICINES MAY INTERACT with Hetlioz. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Fluvoxamine or ketoconazole because they may increase the risk of Hetlioz's side effects
  • Rifampin because it may decrease Hetlioz's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hetlioz may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hetlioz:

Use Hetlioz as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Hetlioz by mouth without food.
  • Take Hetlioz before bedtime at the same time each night.
  • Swallow Hetlioz whole. Do not break, crush, or chew before swallowing.
  • After you take Hetlioz, limit your activities to those necessary to prepare for bed.
  • If you miss a dose of Hetlioz, skip the missed dose. Do not take the dose in the morning or take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hetlioz.

Important safety information:

  • Hetlioz may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Hetlioz with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Hetlioz; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Hetlioz may take several weeks or months to work. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Use Hetlioz with caution in the ELDERLY; they may be more sensitive to its effects.
  • Hetlioz should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Hetlioz while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you take Hetlioz, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hetlioz:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; headache; nightmares or unusual dreams; runny or stuffy nose; sneezing; sore throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, or tongue); difficult or painful urination.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Hetlioz:

Store Hetlioz at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hetlioz out of the reach of children and away from pets.

General information:

  • If you have any questions about Hetlioz, please talk with your doctor, pharmacist, or other health care provider.
  • Hetlioz is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Hetlioz or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Hetlioz. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Hetlioz. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Hetlioz.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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