Hetlioz

Generic Name: tasimelteon
Date of Approval: January 31, 2014
Company: Vanda Pharmaceuticals, Inc.

Treatment for: Non-24-Hour Sleep Wake Disorder

FDA Approves Hetlioz

The U.S. Food and Drug Administration (FDA) has approved Hetlioz (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

Non-24 is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. Non-24 affects the majority of totally blind individuals.

The most common side effects in the clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection.

Hetlioz Medication Guide

Read the Medication Guide that comes with Hetlioz before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

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What is the most important information I should know about Hetlioz?

Hetlioz can impair the performance of activities requiring complete mental alertness. After taking this medicine, activity should be limited to preparing for going to bed.

It may take several weeks or months before any benefit of treatment is observed.

What is Hetlioz?

Hetlioz is a melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24), a chronic, circadian rhythm disorder affecting the majority of totally blind individuals.

Who should not take Hetlioz?

Do not take this medicine if you have had an allergic reaction to tasimelteon or any of the ingredients listed below.

Hetlioz should be used during pregnancy only if the potential benefit justifies the potential risks. It should also be used with caution in breast feeding women.

What should I tell my healthcare provider before taking Hetlioz?

Hetlioz may not be right for you. Before starting treatment, tell your healthcare provider about all of your health conditions, including if you:

  • have liver disease
  • are pregnant, planning to become pregnant. It is not known if this medicine will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if this drug can pass into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Medicines can interact with each other, sometimes causing serious side effects, or increasing or decreasing the levels of medicine in your body. Tell your doctor if you are taking any of the following medicines:

  • fluvoxamine (Luvox)
  • rifampin (Rifadin)
  • ketoconazole (Nizoral)
  • ciprofloxacin (Cipro)
  • verapamil (Calan, Isoptin, Verelan)
  • ritonavir (Norvir)
  • nelfinavir (Viracept)
  • clarithromycin (Biaxin)
  • telithromycin (Ketek)
  • nefazodone (Serzone)

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take Hetlioz?

See What is the most important information I should know about Hetlioz?

Take Hetlioz exactly as prescribed. Take one capsule (swallowed whole) at the same time every night before bedtime.

If you are unable to take Hetlioz at approximately the same time on a given night, you should skip the dose.

After taking this medicine, activities should be limited to preparing for going to bed.

It may take several weeks or months before any benefit of treatment is observed.

If you take too much, or overdose, get emergency treatment.

Hetlioz side effects

Hetlioz may cause side effects including:

  • somnolence
  • headache
  • increased alanine aminotransferase
  • nightmares or unusual dreams
  • upper respiratory or urinary tract infection.

Side effects are more likely to occur in elderly (>65 years) patients.

This is not a complete list of side effects. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.

See also: Side effects (in more detail)

How should I store Hetlioz?

Store Hetlioz at room temperature, 68°F to 77°F (20°C to 25°C). Protect from exposure to light and moisture.

Keep Hetlioz and all medicines out of reach of children.

General Information about the safe and effective use of Hetlioz

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not share it with other people, even if they have the same symptoms that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Hetlioz. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.

What are the ingredients in Hetlioz?

Active Ingredient: tasimelteon

Inactive Ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. Each hard gelatin capsule consists of gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #3, and FD&C Yellow #6.

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