Tasimelteon is a sedative that is used to treat non-24-hour sleep-wake disorder in adults.

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

Tasimelteon may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

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 equivalent. 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.

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)

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Refrigerate the suspension. After opening the suspension bottle, discard any unused liquid medication after 5 weeks (for the 48 mL bottle) and after 8 weeks (for the 158 mL bottle).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

After taking tasimelteon, avoid doing anything other than getting ready for bed.

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

Call your doctor at once if you have pain or burning when you urinate.

Side effects may be more likely 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 may report side effects to FDA at 1-800-FDA-1088.

Using tasimelteon with other drugs that make you drowsy can worsen this effect. 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 at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

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

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.