Melatonin receptor agonists
Tasimelteon
The FDA lists this product in 3 strengths and forms.
Indications
Tasimelteon capsule is a melatonin receptor agonist. Tasimelteon capsules are indicated for the treatment of Non 24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 )
1.1Non-24-Hour Sleep-Wake Disorder (Non-24)
Tasimelteon capsules are indicated for the treatment of Non-24-Hour in adults.
Contraindications
None. None ( 4 )
Warnings and precautions
May cause somnolence: After taking tasimelteon, patients should limit their activity to preparing for going to bed, because tasimelteon can impair the performance of activities requiring complete mental alertness ( 5.1 )
5.1Somnolence
After taking tasimelteon, patients should limit their activity to preparing for going to bed. tasimelteon can potentially impair the performance of activities requiring complete mental alertness.
Interactions
Strong CYP1A2 inhibitors (e.g., fluvoxamine): Avoid use of tasimelteon in combination with strong CYP1A2 inhibitors because of increased exposure ( 7.1 , 12.3 ) Strong CYP3A4 inducers (e.g., rifampin): Avoid use of tasimelteon in combination with rifampin or other CYP3A4 inducers, because of decreased exposure ( 7.2 , 12.3 )
7.1Strong CYP1A2 Inhibitors
(e.g., fluvoxamine) Avoid use of tasimelteon in combination with fluvoxamine or other strong CYP1A2 inhibitors because of a potentially large increase in tasimelteon exposure and greater risk of adverse reactions [see Clinical Pharmacology (12.3) ].
7.2Strong CYP3A4 Inducers
(e.g., rifampin) Avoid use of tasimelteon in combination with rifampin or other CYP3A4 inducers because of a potentially large decrease in tasimelteon exposure with reduced efficacy [see Clinical Pharmacology (12.3) ].
At a glance
- Brand name
- Tasimelteon
- Drug class
- Melatonin receptor agonists
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- MSN
- Status
- Prescription
- FDA approval
- 12 Jan 2023
- Application
- ANDA211654-001
- RxCUI
- 1490468



