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Tasimelteon – Amneal is the generic version of Hetlioz oral capsules.

Tasimelteon – Amneal is available as a 20 mg oral capsule.

Tasimelteon – Amneal is a melatonin receptor agonist used to treat:

• Non-24-hour sleep-wake disorder (non-24)
• Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS)

Tasimelteon – Amneal is a melatonin receptor agonist which means that it acts like melatonin. Melatonin is a natural hormone that your body makes when it’s dark to help maintain a normal sleeping cycle. The exact way in which Tasimelteon – Amneal works is not known. It’s thought that because Tasimelteon – Amneal works like melatonin, it can regulate your sleep by helping you sleep at night and stay awake during the day.

The recommended dosage of Tasimelteon – Amneal in adults is 20 mg one hour before bedtime, at the same time every night.

Tasimelteon – Amneal is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Tasimelteon – Amneal:

• Headache
• Abnormal liver tests
• Nightmares or abnormal dreams
• Upper respiratory tract infection
• Urinary tract infection

Serious side effects are rare with Tasimelteon – Amneal.

The following medications may interact with Tasimelteon – Amneal:

• Strong CYP1A2 Inhibitors (e.g., fluvoxamine): Avoid use of Tasimelteon – Amneal in combination with fluvoxamine or other strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions
• Strong CYP3A4 Inducers (e.g., rifampin): Avoid use of Tasimelteon – Amneal in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy
• Beta-Adrenergic Receptor Antagonists (e.g., acebutolol, metoprolol): Beta-adrenergic receptor antagonists have been shown to reduce the production of melatonin via specific inhibition of beta-1 adrenergic receptors Nighttime administration of beta-adrenergic receptor antagonists may reduce the efficacy of Tasimelteon – Amneal

Amneal Pharmaceuticals

It is not known if Tasimelteon – Amneal can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

• Tasimelteon