Hetlioz LQ
- Generic Name: tasimelteon oral suspension
- Brand Name: Hetlioz LQ
- Drug Class: , Melatonin Receptor Agonists
Hetlioz LQ(Tasimelteon Oral Suspension) side effects drug center
Hetlioz LQ Side Effects Center
What Is Hetlioz LQ?
Hetlioz LQ (tasimelteon) is a melatonin receptor agonist used to treat nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in pediatric patients 3 years to 15 years of age.
What Are Side Effects of Hetlioz LQ?
Side effects of Hetlioz LQ include:
- headache,
- increased alanine aminotransferase,
- nightmare/abnormal dreams,
- upper respiratory tract infection, and
- urinary tract infection (UTI)
Dosage for Hetlioz LQ
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 LQ one hour before bedtime, at the same time every night.
Hetlioz LQ In Children
Safety and effectiveness of Hetlioz LQ oral suspension for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) have been established in pediatric patients 3 years and older.
Safety and effectiveness of Hetlioz LQ for the treatment of nighttime sleep disturbances in SMS have not been established in patients younger than 3 years old.
What Drugs, Substances, or Supplements Interact with Hetlioz LQ?
Hetlioz LQ may interact with other medicines such as:
- strong CYP1A2 inhibitors (e.g., fluvoxamine),
- strong CYP3A4 inducers (e.g., rifampin), and
- beta-adrenergic receptor antagonists (e.g., acebutolol, metoprolol)
Tell your doctor all medications and supplements you use.
Hetlioz LQ During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Hetlioz LQ; it is unknown how it would affect a fetus. It is unknown if Hetlioz LQ passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Hetlioz LQ (tasimelteon) Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Hetlioz LQ Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have pain or burning when you urinate.
Side effects may be more likely in older adults.
Common side effects may include:
- headache;
- abnormal liver function tests;
- strange dreams, nightmares; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Hetlioz LQ (Tasimelteon Oral Suspension)
Hetlioz LQ Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
More than 2080 subjects have been treated with at least one dose of HETLIOZ, of which more than 380 have been treated for > 26 weeks and more than 170 have been treated for > 1 year.
Non-24-Hour Sleep-Wake Disorder (Non-24)
A 26-week, parallel-arm placebo-controlled study (Study 1) evaluated HETLIOZ (n=42) compared to placebo (n=42) in patients with Non-24. A randomized-withdrawal, placebo-controlled study of 8 weeks duration (Study 2) also evaluated HETLIOZ (n=10), compared to placebo (n=10), in patients with Non-24.
In placebo-controlled studies, 6% of patients exposed to HETLIOZ discontinued treatment due to an adverse event, compared with 4% of patients who received placebo.
Table 2 shows the incidence of adverse reactions from Study 1.
Table 2: Adverse Reactions in Study 1
| HETLIOZ N=42 | Placebo N=42 | |
| Headache | 17 % | 7 % |
| Alanine aminotransferase increased | 10 % | 5 % |
| Nightmare/abnormal dreams | 10 % | 0 % |
| Upper respiratory tract infection | 7 % | 0 % |
| Urinary tract infection | 7 % | 2 % |
| *Adverse reactions with an incidence > 5% and at least twice as high on HETLIOZ than on placebo are displayed. | ||
Nighttime Sleep Disturbances In Smith-Magenis Syndrome (SMS)
A 9-week, double-blind, randomized, placebo-controlled, two-period crossover study evaluated HETLIOZ (capsules and oral suspension; n=25) compared to placebo (n=26) in the treatment of nighttime sleep disturbances in patients with Smith-Magenis Syndrome. Pediatric patients (n=11, age 3 to 15 years) received HETLIOZ LQ oral suspension, and patients ≥16 years of age (n=14) received HETLIOZ capsules.
Adverse reactions were similar in patients treated for Non-24 and patients with Smith-Magenis syndrome treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQ oral suspension, and patients ≥16 years of age who received HETLIOZ capsules.
Read the entire FDA prescribing information for Hetlioz LQ (Tasimelteon Oral Suspension)
&Copy; Hetlioz LQ Patient Information is supplied by Cerner Multum, Inc. and Hetlioz LQ Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.