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Tasimelteon

Tasimelteon (brand name: Hetlioz) is a medication used to treat non-24-hour sleep-wake disorder (Non-24), primarily in blind individuals who have difficulty maintaining a regular sleep-wake cycle due to the lack of light perception. It is also approved for the treatment of nighttime sleep disturbances in individuals with Smith-Magenis Syndrome. Tasimelteon works by acting on the body’s melatonin receptors, helping to regulate the sleep-wake cycle.



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Frequently Asked Questions

How long does it take for Tasimelteon to start working?
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It may take several weeks to months of continuous use before the full effects of Tasimelteon on sleep patterns are seen. Consistency in taking the medication at the same time each night is key to its effectiveness.

Can I take Tasimelteon with food?
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No, it is recommended to take Tasimelteon on an empty stomach, as food can reduce its absorption and effectiveness.

What should I do if I miss a dose of Tasimelteon?
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If you miss a dose, skip the missed dose and take the next dose at your regular time the following night. Do not double up to make up for the missed dose.

Is Tasimelteon safe for long-term use?
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Tasimelteon is generally safe for long-term use when taken as prescribed. Regular follow-up with your healthcare provider is recommended to monitor for side effects, especially liver function.

Can sighted people take Tasimelteon for sleep problems?
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Tasimelteon is specifically approved for individuals with Non-24-hour sleep-wake disorder and Smith-Magenis Syndrome. For other sleep problems, medications like melatonin, ramelteon, or other sleep aids may be more appropriate.

Comprehensive Drug Guide

How Does Tasimelteon Work?

Tasimelteon works by selectively binding to melatonin receptors (MT1 and MT2) in the brain. These receptors are involved in the regulation of the body’s circadian rhythms, which control the sleep-wake cycle. By activating these receptors, Tasimelteon helps to synchronize the internal body clock with the 24-hour day, aiding sleep regulation, especially in people with non-24-hour sleep-wake disorder who lack the external cue of light.



Common Dosages

  • 20 mg oral capsule

Typical Dosing

  • The typical dose is 20 mg taken once daily before bedtime, at the same time every night. It is important to take Tasimelteon consistently for it to regulate the circadian rhythm effectively.


Typical Dosing

FDA Approved Indications

  • Non-24-hour sleep-wake disorder (Non-24), primarily in blind individuals.
  • Nighttime sleep disturbances in patients with Smith-Magenis Syndrome.


Who Shouldn't Take Tasimelteon?

  • Known hypersensitivity to tasimelteon or any of the components in the formulation.

Advice From The Pharmacist

  • Take Tasimelteon at the same time every night before going to bed. It may take a few weeks or months for the medication to regulate your sleep-wake cycle, so consistency is important.
  • Do not take with food, as food can delay the absorption of tasimelteon and reduce its effectiveness. Take the medication on an empty stomach.
  • Be patient: It may take several weeks of continuous use before you notice improvements in your sleep pattern.

Side Effects of Tasimelteon

Common Side Effects

  • Headache
  • Nightmares or abnormal dreams
  • Elevated liver enzymes
  • Drowsiness
  • Upper respiratory tract infections

Uncommon/Severe Side Effects

  • Severe allergic reactions such as rash, swelling, or difficulty breathing.
  • Liver toxicity: Although rare, tasimelteon may affect liver function. Regular monitoring of liver enzymes may be required.

Risks and Warnings of Tasimelteon

  • Delayed Onset of Effect: Tasimelteon may take weeks or even months to show full effects, as it gradually works to reset the body’s circadian rhythm. Patients should be advised to continue taking the medication as prescribed, even if they do not see immediate results.
  • Liver Function Monitoring: In rare cases, tasimelteon can cause elevated liver enzymes. Patients with pre-existing liver conditions may need liver function tests before starting treatment.
  • Drowsiness: Tasimelteon can cause daytime drowsiness in some patients. Avoid activities that require alertness, such as driving, until you know how the medication affects you.

Interactions with Tasimelteon

Common Drug Interactions

  • CYP1A2 and CYP3A4 inhibitors: Medications that inhibit these enzymes (e.g., fluvoxamine, ketoconazole) may increase tasimelteon levels in the body, leading to an increased risk of side effects.
  • CYP3A4 inducers: Medications such as rifampin or carbamazepine may decrease the effectiveness of tasimelteon by reducing its levels in the body.
  • Alcohol: Drinking alcohol may increase the sedative effects of tasimelteon and should be avoided.

Alternatives to Tasimelteon

  • Melatonin Supplements: Over-the-counter melatonin supplements may be used to regulate the sleep-wake cycle, though they are generally less effective than prescription medications like tasimelteon for Non-24.
  • Ramelteon (Rozerem): Another melatonin receptor agonist used for insomnia but not specifically approved for Non-24.
  • Circadian rhythm therapy: Light therapy (for sighted individuals) and maintaining a strict sleep-wake schedule may help manage sleep disorders.