Tasimelteon

Tasimelteon is a sedative that treats non-24-hour sleep-wake disorder in adults.

Tasimelteon is also used to help with nighttime sleep problems in people who have a genetic disorder called Smith-Magenis Syndrome (SMS). The capsule form of tasimelteon is for individuals with SMS who are at least 16 years old. The oral suspension (liquid) form is for children with SMS who are between 3 and 15 years old.

Tasimelteon may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine without food, 1 hour before your normal bedtime at the same time each night.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help. Do not allow a young child to use tasimelteon without help from an adult.

Swallow the capsule whole and do not crush, chew, break, or open it.

Tasimelteon capsules are for use in people 16 years and older. Tasimelteon oral suspension is for use only in children 3 to 15 years old.

Shake the oral suspension for at least 30 seconds before you measure a dose. Use the supplied syringe or a dose-measuring device (not a kitchen spoon). Do not remove the syringe adapter from the bottle neck. Recap the bottle and refrigerate after each use.

The capsules and liquid are not the same. Avoid medication errors by using only the form your doctor prescribes.

Doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

You may not fully benefit from this medicine for several weeks or months.

Store capsules at room temperature away from moisture, heat, and light.

Store the liquid medicine in the refrigerator. Throw away any leftover liquid 5 weeks after opening the 48 mL bottle, or 8 weeks after opening the 158 mL bottle.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have allergies.

Tell your doctor if you have ever had:

• liver disease; or
• if you smoke.

Tell your doctor if you are pregnant or breastfeeding.

Do not give tasimelteon to a child without medical advice. Tasimelteon is approved to treat nighttime sleep problems only in children who have SMS and are at least 3 years old. Tasimelteon is not approved to treat non-24-hour sleep-wake disorder in anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have pain or burning when you urinate.

Side effects may happen more often in older adults.

Common side effects of tasimelteon may include:

• headache;
• abnormal liver function tests;
• strange dreams, nightmares; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Insomnia:

20 mg orally once per day Comments:-Take before bedtime, at the same time every night.-Take without food.Use: Treatment of Non-24-Hour Sleep-Wake Disorder (Non-24)

Skip the dose if you cannot take it at the regular time on a given night.

Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

After taking tasimelteon, do not do anything except get ready for bed.

Using tasimelteon with other drugs that make you drowsy can make you feel even more tired. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications together. Some drugs can change the amount of other drugs in your blood, which may increase side effects or make the medications not work as well.

Other drugs may affect tasimelteon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.