Hetlioz

Hetlioz is a prescription medication used to treat a serious, chronic circadian rhythm disorder known as non-24-hour sleep-wake disorder (Non-24). Non-24 affects up to 70% of people who are totally blind. Hetlioz belongs to a group of drugs called melatonin MT1 and MT2 receptor agonists. These work by mimicking the natural substances that are involved with sleep-wake cycles (circadian rhythms).

This medication comes as a capsule. It is taken once a day at night without food.

Common side effects include headache, nightmares, or unusual dreams. Hetlioz can also cause drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you.

Hetlioz is a prescription medication used to treat non-24-hour sleep-wake disorder.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Vanda Pharmaceuticals Inc.

Common side effects of Hetlioz include the following:

• headaches
• unusual dreams
• nightmares
• upper airway infection
• urinary tract infection

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block the enzyme CYP1A2 such as zileuton (Zyflo), amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), propafenone (Rythmol), verapamil (Calan, Covera, Isoptin), cimetidine (Tagamet), famotidine (Pepcid), birth control pills, acyclovir (Zovirax), ticlopidine (Ticlid), ciprofloxacin (Cipro), and fluvoxamine (Luvox)

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with this medication, and certain precautions should be followed:

• After taking Hetlioz, you should limit your activity to getting ready for bed. This medication can potentially impair the performance of activities requiring complete mental alertness. In addition, do not drive or operate heavy machinery after taking this medication.
• Do not take this medication if you are allergic to it or to any of the inactive ingredients.

   

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Hetlioz, there are no specific foods that you must exclude from your diet.

Before taking Hetlioz, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Hetlioz or to any of its ingredients
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Hetlioz crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Hetlioz.

Take Hetlioz exactly as prescribed.

• This medication comes as a capsule. It is taken once a day at night without food.
• Take Hetlioz before bedtime at the same time every night.
• Skip a dose that night if you cannot take Hetlioz at about the same time on a given night.

• Limit your activities and prepare for going to bed after taking Hetlioz. Hetlioz can potentially impair the performance of activities requiring complete mental alertness.
• Because of individual differences in sleep cycles, daily use for several weeks or months may be necessary before benefit from Hetlioz is observed.
• To swallow the capsule whole.
• Smoking can cause a reduction in how Hetlioz works.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose is 20 mg prior to bedtime, at same time every night.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store this medication at room temperature.
• Protect from light and moisture.
• Keep this and all other medications out of the reach of children.