Hetlioz
(Tasimelteon)Dosage & Administration
Indicated Population | Dosage Form | Body Weight | Recommended Dosage | ||||||
Non-24 ( Adults The recommended dosage of HETLIOZ capsules in adults is 20 mg one hour before bedtime, at the same time every night. Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months. | |||||||||
Adults | Capsules | Not applicable | 20 mg one hour prior to bedtime | ||||||
Nighttime sleep disturbances in SMS ( Patients 16 years of Age and Older The recommended dosage of HETLIOZ capsules in patients 16 years and older is 20 mg one hour before bedtime, at the same time every night. Pediatric Patients 3 Years to 15 Years of Age The recommended dosage of HETLIOZ LQ oral suspension in pediatric patients 3 years to 15 years of age is based on body weight . Administer HETLIOZ one hour before bedtime, at the same time every night.
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Patients 16 years of age and older | Capsules | Not applicable | 20 mg one hour prior to bedtime | ||||||
Pediatric Patients 3 to 15 years of age | Oral Suspension | ≤ 28 kg | 0.7 mg/kg one hour before bedtime | ||||||
| ≥ 28 kg | 20 mg one hour prior to bedtime | ||||||||
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Hetlioz Prescribing Information
Indications and Usage (HETLIOZ is a melatonin receptor agonist.
HETLIOZ LQ oral suspension is indicated for the treatment of:
| 12/2020 | ||||||
Dosage and Administration (HETLIOZ capsules and HETLIOZ LQ oral suspension are not substitutable [see Clinical Pharmacology ]. Patients 16 years of Age and Older The recommended dosage of HETLIOZ capsules in patients 16 years and older is 20 mg one hour before bedtime, at the same time every night. Pediatric Patients 3 Years to 15 Years of Age The recommended dosage of HETLIOZ LQ oral suspension in pediatric patients 3 years to 15 years of age is based on body weight . Administer HETLIOZ one hour before bedtime, at the same time every night.
Administer HETLIOZ capsules and HETLIOZ LQ oral suspension without food [see Clinical Pharmacology ] .If a patient is unable to take HETLIOZ at approximately the same time on a given night, they should skip that dose and take the next dose as scheduled. HETLIOZ LQ Oral Suspension See " Instructions for Use" for complete administration instructions. Shake HETLIOZ LQ oral suspension well for at least 30 seconds before every administration. Remove seal and insert press-in bottle adapter (included in the package) into the neck of the bottle until a tight seal is made. Turn the bottle upside down and withdraw the prescribed amount of HETLIOZ LQ oral suspension from the bottle. Leave the press-in bottle adapter in place on bottle neck and replace cap on bottle. Store refrigerated. After opening, discard after 5 weeks (for the 48 mL bottle) and after 8 weeks (for the 158 mL bottle). | 12/2020 |
HETLIOZ is a melatonin receptor agonist.
- HETLIOZ capsules are indicated for the treatment of:
- Non-24-Hour Sleep-Wake Disorder (Non-24) in adults ()
1 INDICATIONS AND USAGEHETLIOZ is a melatonin receptor agonist.
- HETLIOZ capsules are indicated for the treatment of:
- Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
- Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
HETLIOZ LQ oral suspension is indicated for the treatment of:
- Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age
1.1 Non-24-Hour Sleep-Wake Disorder (Non-24)- HETLIOZ capsules are indicated for the treatment of Non-24 in adults.
1.2 Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)- HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older.
- HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.
- Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older ()
1 INDICATIONS AND USAGEHETLIOZ is a melatonin receptor agonist.
- HETLIOZ capsules are indicated for the treatment of:
- Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
- Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
HETLIOZ LQ oral suspension is indicated for the treatment of:
- Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age
1.1 Non-24-Hour Sleep-Wake Disorder (Non-24)- HETLIOZ capsules are indicated for the treatment of Non-24 in adults.
1.2 Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)- HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older.
- HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.
HETLIOZ LQ oral suspension is indicated for the treatment of:
- Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age ()
1 INDICATIONS AND USAGEHETLIOZ is a melatonin receptor agonist.
- HETLIOZ capsules are indicated for the treatment of:
- Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
- Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
HETLIOZ LQ oral suspension is indicated for the treatment of:
- Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age
1.1 Non-24-Hour Sleep-Wake Disorder (Non-24)- HETLIOZ capsules are indicated for the treatment of Non-24 in adults.
1.2 Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)- HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of age and older.
- HETLIOZ LQ oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in pediatric patients 3 to 15 years of age.
Indicated Population | Dosage Form | Body Weight | Recommended Dosage | ||||||
Non-24 ( Adults The recommended dosage of HETLIOZ capsules in adults is 20 mg one hour before bedtime, at the same time every night. Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months. | |||||||||
Adults | Capsules | Not applicable | 20 mg one hour prior to bedtime | ||||||
Nighttime sleep disturbances in SMS ( Patients 16 years of Age and Older The recommended dosage of HETLIOZ capsules in patients 16 years and older is 20 mg one hour before bedtime, at the same time every night. Pediatric Patients 3 Years to 15 Years of Age The recommended dosage of HETLIOZ LQ oral suspension in pediatric patients 3 years to 15 years of age is based on body weight . Administer HETLIOZ one hour before bedtime, at the same time every night.
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Patients 16 years of age and older | Capsules | Not applicable | 20 mg one hour prior to bedtime | ||||||
Pediatric Patients 3 to 15 years of age | Oral Suspension | ≤ 28 kg | 0.7 mg/kg one hour before bedtime | ||||||
| ≥ 28 kg | 20 mg one hour prior to bedtime | ||||||||
- HETLIOZ capsules and HETLIOZ LQ oral suspension are not substitutable ()
2.1 Non-Interchangeability between HETLIOZ Capsules and HETLIOZ LQ Oral SuspensionHETLIOZ capsules and HETLIOZ LQ oral suspension are not substitutable
[see Clinical Pharmacology ]. - Administer at the same time every night (,
2.2 Recommended Dosage for HETLIOZ Capsules for Non-24Adults
The recommended dosage of HETLIOZ capsules in adults is 20 mg one hour before bedtime, at the same time every night.Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months.
)2.3 Recommended Dosage for HETLIOZ Capsules and HETLIOZ LQ Oral Suspension for Nighttime Sleep Disturbances in SMSPatients 16 years of Age and Older
The recommended dosage of HETLIOZ capsules in patients 16 years and older is 20 mg one hour before bedtime, at the same time every night.Pediatric Patients 3 Years to 15 Years of Age
The recommended dosage of HETLIOZ LQ oral suspension in pediatric patients 3 years to 15 years of age is based on body weight . Administer HETLIOZ one hour before bedtime, at the same time every night.Table 1: Recommended Dosage of HETLIOZ LQ Oral Suspension for the Treatment of Nighttime Sleep Disturbances in SMS in Pediatric Patients 3 Years to 15 Years of Age Body WeightDaily Dose (oral suspension)≤28 kg 0.7 mg/kg one hour before bedtime >28 kg 20 mg one hour before bedtime - Take without food ()
2.4 Important Administration InformationAdminister HETLIOZ capsules and HETLIOZ LQ oral suspension without food
[see Clinical Pharmacology ].If a patient is unable to take HETLIOZ at approximately the same time on a given night, they should skip that dose and take the next dose as scheduled.
HETLIOZ LQ Oral SuspensionSee " Instructions for Use" for complete administration instructions.
Shake HETLIOZ LQ oral suspension well for at least 30 seconds before every administration. Remove seal and insert press-in bottle adapter (included in the package) into the neck of the bottle until a tight seal is made. Turn the bottle upside down and withdraw the prescribed amount of HETLIOZ LQ oral suspension from the bottle. Leave the press-in bottle adapter in place on bottle neck and replace cap on bottle. Store refrigerated. After opening, discard after 5 weeks (for the 48 mL bottle) and after 8 weeks (for the 158 mL bottle).
Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white.
Oral suspension: 4 mg/mL white to slightly yellow opaque suspension in 48 mL or 158 mL bottles.
None.
May cause somnolence: After taking HETLIOZ, patients should limit their activity to preparing for going to bed, because HETLIOZ can impair the performance of activities requiring complete mental alertness (
After taking HETLIOZ, patients should limit their activity to preparing for going to bed. HETLIOZ can potentially impair the performance of activities requiring complete mental alertness.