HETLIOZ: Oral capsule (20mg)

Detailed Information

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What is this Medicine?

TASIMELTEON (ta si MEL tee on) is used to treat sleep-wake cycle disruptions in people who are blind.

In-Depth Information

HETLIOZ 20mg Capsule

NDC: 430680220

Prescription Required
Not a Controlled Drug
(CSA Schedule)
FDA Approved

FDA approved for the following conditions:
Non-24-hour Sleep-wake Disorder

Storage Information
Protect from light
Protect from moisture
Store at 77 degrees F; excursions permitted to 59-86 degrees F

HETLIOZ 20mg Capsule

Ingredients

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Reported Side Effects for HETLIOZ 20mg Capsule

Infection Incidence: <7.0%* Severity: MILD
Onset: DELAYED

Drowsiness Incidence: >10.0%* Severity: MILD
Onset: EARLY

Elevated Hepatic Enzymes Incidence: 10.0%* Severity: MODERATE
Onset: DELAYED

Nightmares Incidence: 10.0%* Severity: MILD
Onset: EARLY

Headache Incidence: 17.0%* Severity: MILD
Onset: EARLY

*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.

Daily Life Interactions for HETLIOZ 20mg Capsule

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

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Major Lifestyle Interaction

Tobacco and HETLIOZ 20mg Capsule(Tasimelteon)

Tobacco and Tasimelteon(Tasimelteon)

Tasimelteon may not work as well in treating your condition if you smoke Tobacco products. Talk to your healthcare provider if you are a smoker or change your smoking habits while taking Tasimelteon.

Moderate Lifestyle Interaction

Alcohol and HETLIOZ 20mg Capsule(Tasimelteon)

Alcohol and Tasimelteon(Tasimelteon)

Your doctor may want you to avoid Alcohol because of an increased risk of side effects from Tasimelteon if you drink. Decreased alertness, drowsiness, falls, or other side effects may occur. Do not drive or operate machinery if you are drinking alcohol-containing beverages. If you notice slurred speech, confusion, or extreme drowsiness, contact your health care provider immediately.

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Pregnancy & Lactation Information

FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

THIRD Trimester

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.

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