Pharmaceutical Raw Materials Tasimelteon / Hetlioz CAS 609799-22-6 For good Sleep

Tasimelteon is a drug approved by the U.S. Food and Drug Administration (FDA)in January 2014 for the treatment of non-24-hour sleep-wake disorder (also called Non-24, N24 and N24HSWD).In June 2014, the European Medicines Agency accepted an EU filing application for tasimelteon and in July 2015, the drug was approved in Europe for the treatment of non-24-hour sleep-wake rhythm disorder in totally blind adults,but not in the rarer case of non-24 in sighted people.

Tasimelteon is a selective agonist for the melatonin receptors MT1 and MT2, similar to other members of the melatonin receptor agonist class of which ramelteon (2005) and agomelatine (2009) were the first approved.As a treatment for N24HSWD, as with melatonin or other melatonin derivatives, the patient may experience improved sleep timing while taking the drug. Reversion to baseline sleep performance occurs within a month of discontinuation.

Important safety information

Tasimelteon may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use tasimelteon with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking tasimelteon; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Tasimelteon may take several weeks or months to work. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.Use tasimelteon with caution in the ELDERLY; they may be more sensitive to its effects.

Tasimelteon should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking tasimelteon while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you take tasimelteon, check with your doctor. Discuss any possible risks to your baby.

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