Non-Interchangeability between HETLIOZ Capsules and HETLIOZ LQ Oral Suspension

HETLIOZ capsules and HETLIOZ LQ oral suspension are not substitutable [see Clinical Pharmacology (12.3)].

Recommended Dosage for HETLIOZ Capsules for 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.

Recommended Dosage for HETLIOZ Capsules and HETLIOZ LQ Oral Suspension for 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 (Table 1). Administer HETLIOZ one hour before bedtime, at the same time every night.

Important Administration Information

Administer HETLIOZ capsules and HETLIOZ LQ oral suspension without food [see Clinical Pharmacology (12.3)].

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).