Tasimelteon

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Pregnancy Category: C

Lactation: Unknown if distributed in human breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Tasimelteon is a prescription medication used to treat non-24-hour sleep-wake disorder.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block the enzyme CYP1A2 such as zileuton (Zyflo), amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), propafenone (Rythmol), verapamil (Calan, Covera, Isoptin), cimetidine (Tagamet), famotidine (Pepcid), birth control pills, acyclovir (Zovirax), ticlopidine (Ticlid), ciprofloxacin (Cipro), and fluvoxamine (Luvox)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Take tasimelteon exactly as prescribed.

• This medication comes as a capsule. It is taken once a day at night without food.
• Take tasimelteon before bedtime at the same time every night.
• Skip a dose that night if you cannot take tasimelteon at about the same time on a given night.

• Limit your activities and prepare for going to bed after taking tasimelteon. Tasimelteon can potentially impair the performance of activities requiring complete mental alertness.
• Because of individual differences in sleep cycles, daily use for several weeks or months may be necessary before benefit from tasimelteon is observed.
• To swallow the capsule whole.
• Smoking can cause a reduction in how tasimelteon works.

   

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol may increase drowsiness caused by tasimelteon.

Storage

Oral

25°C (may be exposed to 15–30°C).1 Protect from light and moisture.1

Use tasimelteon as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine before bedtime at the same time every night.
• Take tasimelteon without food.
• Swallow whole. Do not chew, break, or crush.
• After you take this medicine, only do things needed to get ready for bed.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Effect may take weeks or months (due to individual differences in circadian rhythms)

Time to Peak

Fasting: ~0.5 to 3 hours (increased by ~1.75 hours with a high-fat meal)

Half-Life Elimination

~1 to 2 hours

Protein Binding

~90%

In elderly subjects, tasimelteon exposure increased by ~2-fold compared with younger adults.

The mean overall exposure of tasimelteon was ~20% to 30% greater in female than in male subjects.

There are no contraindications listed in the manufacturer's labeling.

Applies to tasimelteon: oral capsule

Nervous system

Very common (10% or more): Headache (17%)
Frequency not reported: Somnolence[Ref]

Hepatic

Very common (10% or more): Increased ALT (10%)[Ref]

Psychiatric

Very common (10% or more): Nightmare/abnormal dreams (10%)

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection[Ref]

Some side effects of tasimelteon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Administration advice:
-When this drug cannot be taken at approximately the same time on a given night, skip the dose that evening and return to the normal dose schedule the following night.
-Swallow drug capsule whole; do not chew, break, or crush.

Storage requirements:
-Protect from light and moisture.
-Store at room temperature (25 degrees Celsius/77 degrees Fahrenheit); excursions permitted to 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).

General:
-There is not any evidence showing this drug has potential for abuse or physical dependence.
-For overdosage, general symptomatic and supportive measures should be used along with immediate gastric lavage and IV fluids where appropriate. It is not known if hemodialysis will effectively reduce exposure in overdose cases.

Patient advice:
-After taking this drug at night, only do activities needed to get ready for bed since this drug may cause you to feel drowsy and less mentally alert.
-Do not smoke while taking this drug as it may reduce the drug's effectiveness.
-Avoid drinking alcohol while taking this drug as it may slow your actions.
-It may take several weeks or months for you to notice any benefit from this drug due to the individual differences in circadian rhythms.
-Do not take 2 doses of this drug at the same time or extra doses. If you skip a dose, return to your normal dose schedule the next night.
-Do not store this drug in the bathroom; protect it from moisture and light.