Source: FDA, National Drug Code (US) Revision Year: 2020
HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
The recommended dosage of HETLIOZ is 20 mg per day taken before bedtime, at the same time every night.
Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months.
HETLIOZ should be taken without food [see Clinical Pharmacology (12.3)].
There is limited premarketing clinical experience with the effects of an overdosage of HETLIOZ.
As with the management of any overdose, general symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Respiration, pulse, blood pressure, and other appropriate vital signs should be monitored, and general supportive measures employed.
While hemodialysis was effective at clearing HETLIOZ and the majority of its major metabolites in patients with renal impairment, it is not known if hemodialysis will effectively reduce exposure in the case of overdose.
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. Contact a poison control center for current information on the management of overdose.
Store HETLIOZ 20 mg capsules at controlled room temperature, 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect HETLIOZ 20 mg capsules from exposure to light and moisture.
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