Classes
DEA Class; Rx
Common Brand Names; Hetlioz
- Sedative/Hypnotics;
- Melatonin Receptor Agonists
Description
Melatonin receptor agonist
Used for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome
May take weeks or months for drug effect to occur in non-24 due to variable circadian rhythms
Indications
Indicated for the treatment of non-24-hour sleep-wake disorder.
Adverse Effects
Headache (17%)
Increased ALT (10%)
Nightmares/abnormal dreams (10%)
Upper respiratory infections (7%)
Urinary tract infections (7%)
Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS)
Warnings
After administration, advise patients to limit activity to prepare for going to bed
May potentially impair performance of activities requiring complete mental alertness
Pregnancy and Lactation
Available postmarketing case reports use in pregnant females are not sufficient to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
No data available on drug presence or its metabolites in human or animal milk, effects on breastfed infants, effects on milk production
Maximum Dosage
20 mg/day PO.
20 mg/day PO.
16 to 17 years: 20 mg/day PO.
13 to 15 years weighing more than 28 kg: 20 mg/day PO.
13 to 15 years weighing 28 kg or less: 0.7 mg/kg/day PO.
3 to 12 years weighing more than 28 kg: 20 mg/day PO.
3 to 12 years weighing 28 kg or less: 0.7 mg/kg/day PO.
1 to 2 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tasimelteon
capsule
- 20mg (Hetlioz)
