Hetlioz Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Hetlioz Capsule (tasimelteon) is a prescription sedative belonging to the melatonin receptor agonist class. It is used to treat non-24-hour sleep-wake disorder in adults and nighttime sleep problems in people 16 years and older with Smith-Magenis Syndrome. It works by acting on the same brain receptors as melatonin to help regulate the body's sleep-wake cycle. Hetlioz is not a controlled substance and is considered non-habit-forming.

What is Hetlioz Capsule

Hetlioz is a prescription sedative (hypnotic) that affects substances in your body involved in regulating your sleep-wake cycle. It is not a controlled substance and is considered non-habit-forming.

Hetlioz Capsule uses

• Treats non-24-hour sleep-wake disorder (Non-24) in adults, whose internal body clock does not match a normal 24-hour day, causing nighttime insomnia and daytime sleepiness
• Treats nighttime sleep problems in people with Smith-Magenis Syndrome (SMS); the capsule form is for people 16 years and older

Benefits of Hetlioz Capsule

• Helps improve the consistency, timing, and duration of nighttime sleep
• Reduces daytime drowsiness linked to these circadian rhythm disorders
• Non-habit-forming and not a controlled substance

How Hetlioz Capsule works

Tasimelteon attaches to the same brain receptors that normally respond to melatonin, a natural hormone that helps control sleep. By acting on these receptors, it helps regulate the body's internal sleep-wake cycle (circadian rhythm).

Hetlioz Capsule dosage

Take on an empty stomach, about one hour before your usual bedtime, at the same time every night. Swallow the capsule whole; do not crush, chew, break, or open it. Capsules are for people 16 years and older; the liquid form is used for younger children with SMS and is not equivalent to the capsule.

After taking it, limit your activities to just getting ready for bed. It may take several weeks or months to notice the full benefit, so continue taking it as directed and at a consistent nightly time. If you miss a dose for the night, skip it and take the next dose at the regular time; do not take two doses at once.

Available forms and strengths

• Capsule (20 mg)
• Oral suspension (liquid, 4 mg/mL)

Side effects of Hetlioz Capsule

Common

• Headache
• Drowsiness or feeling groggy/sleepy
• Nightmares or unusual/strange dreams
• Upper respiratory tract infection (stuffy nose, sneezing, sore throat, cold symptoms)
• Urinary tract or bladder infection
• Increase in a liver enzyme called ALT
• Nausea or dizziness in some cases

Serious

• Signs of a serious allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat
• Racing heart, fever, or general ill feeling
• Swollen lymph nodes
• Trouble swallowing or throat tightness
• Pain or burning when urinating

Warnings and precautions

• After taking this medicine, you should start getting ready for bed right away, since it can impair mental alertness and activities.
• Avoid combining this medicine with certain drugs that strongly affect how it's broken down in the body, such as fluvoxamine (which can raise its levels) or rifampin (which can lower its effectiveness).
• Taking this medicine with food can reduce how well it is absorbed and how well it works, so it should be taken on an empty stomach.
• The capsules contain inactive ingredients, including lactose and a dye called Orange Yellow S (E110), which may trigger sensitivities or allergic reactions in some people.
• Smoking can lower the blood levels of this medicine and make it not work as well. Tell your doctor if you smoke, start smoking, or quit smoking.
• People 65 or older may be at greater risk of certain side effects, since drug levels can build up higher in older adults.
• It isn't known if or how this medicine could affect pregnancy or harm a fetus. Tell your doctor if you are pregnant or plan to become pregnant, so they can weigh the benefits and risks.
• It isn't known if this medicine passes into breast milk. Tell your doctor if you are breastfeeding or plan to, so they can advise you.
• No adjustment is required for mild or moderate liver impairment; Hetlioz is not recommended in severe hepatic impairment. This medicine can raise liver enzyme levels and is not recommended for people with severe liver problems. 
• Tell your doctor if you have ever had liver disease.
• It isn't known exactly how alcohol affects this medicine, but drinking alcohol may increase sleepiness and problems with coordination and alertness while taking it.
• This medicine can make you drowsy and affect your alertness or coordination. Do not drive or operate machinery after taking it — limit activity to preparing for bed.

Storage

• Store capsules at room temperature away from moisture, heat, and light
• Do not store in the bathroom
• Keep out of the reach of children and pets
• Properly discard this product when it is expired or no longer needed; consult your pharmacist or local waste disposal company about disposal

When to see a doctor

• Get emergency medical help right away if you have signs of a serious allergic reaction, such as hives, trouble breathing, or swelling of your face, lips, tongue, or throat.
• Call your doctor right away if you have pain or a burning feeling when you urinate.
• If you or someone else has taken too much of this medicine, seek emergency medical attention or contact a poison control center right away.

Alternatives

• Melatonin
• Rozerem
• Ramelteon