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Hetlioz is the brand name for tasimelteon oral capsules and suspension.

Hetlioz is available as a 20 mg oral capsule and as Hetlioz LQ which is a 4 mg/mL oral suspension.

Hetlioz is a melatonin receptor agonist and is used for the following:

• Non-24-hour sleep-wake disorder (non-24)
• Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS)

Hetlioz is a melatonin receptor agonist which means that it acts like melatonin. Melatonin is a natural hormone that your body makes when it’s dark to help maintain a normal sleeping cycle. The exact way in which Hetlioz works is not known. It’s thought that because Hetlioz works like melatonin, it can regulate your sleep by helping you sleep at night and stay awake during the day.

Hetlioz is dosed as follows:

• All doses should be taken at the same time every night and on an empty stomach.

Non-24 (adults only):

• The typical dose of Hetlioz capsules is 20 mg by mouth 1 hour before bedtime

Nighttime sleep disturbances in SMS (adults and children):

• Ages 16 and older: The typical dose is 20 mg of Hetlioz capsules by mouth 1 hour before bedtime
• Ages 3 to 15: The typical dose of Hetlioz LQ will depend on the child’s weight. For children weighing (28 kg) or less, the dose is 0.7 mg/kg 1 hour before bedtime. For children weighing more than (28 kg), the dose is 20 mg (5 mL) 1 hour before bedtime

Hetlioz is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Hetlioz:

• Headache
• Abnormal liver tests
• Nightmares or abnormal dreams
• Upper respiratory tract infection
• Urinary tract infection

Serious side effects are rare with Hetlioz.

• The following medications may interact with Hetlioz:
• Strong CYP1A2 inhibitors (e.g., fluvoxamine): Avoid use of Hetlioz inncombination with strong CYP1A2 inhibitors because of increased exposure
• Strong CYP3A4 inducers (e.g., rifampin): Avoid use of Hetlioz in combination with rifampin or other CYP3A4 inducers, because of decreased exposure

Vanda Pharmaceuticals Inc.

It is not known if Hetlioz will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Hetlioz.

• Tasimelteon