Is Daridorexant approved by the FDA?
Daridorexant was approved by the U.S. Food and Drug Administration (FDA) on January 7, 2022, for the treatment of insomnia in adults who have difficulty falling asleep or staying asleep.
What is Daridorexant?
Daridorexant is an oral tablet available in 25 mg and 50 mg dosages. It belongs to a class of medications known as dual orexin receptor antagonists (DORA). Daridorexant works by blocking the activity of orexin, a protein that promotes wakefulness, thereby helping to improve sleep.
Uses
Daridorexant is prescribed to improve sleep onset and maintenance in adults with insomnia. By turning down overactive wake signals, daridorexant helps individuals fall asleep faster and stay asleep longer.
Dosage and Administration
The recommended dose of daridorexant for adults is between 25 mg and 50 mg taken once per night. It should be taken 30 minutes before bedtime, ensuring that the individual can stay in bed for at least 7 hours after taking the medication. If taken with or immediately after a meal, the effectiveness of daridorexant may be delayed.
Side Effects
Common side effects of daridorexant include:
- Headache
- Drowsiness
Serious side effects may include:
- Allergic reactions such as hives, difficulty breathing, and swelling of the face, lips, tongue, or throat
- New or sudden changes in mood or behavior, including depression and suicidal thoughts
- Sleep-related activities such as driving, eating, or making phone calls with no memory of the activity
- Hallucinations or inability to move or talk for several minutes while waking up or falling asleep
- Heart-related issues such as fast or pounding heartbeats, shortness of breath, and dizziness
- Liver problems, indicated by symptoms like loss of appetite, upper right stomach pain, tiredness, dark urine, clay-colored stools, and jaundice
If any serious side effects occur, it is crucial to seek immediate medical attention.
Precautions
Individuals should not take daridorexant if they:
- Have narcolepsy
- Are allergic to daridorexant or any of its inactive ingredients
Before starting daridorexant, inform your doctor if you have a history of:
- Mental illness, depression, or suicidal thoughts
- Drug or alcohol abuse
- Heart rhythm disorders or congestive heart failure
- Daytime sleepiness or breathing problems, including sleep apnea
- Liver problems
Pregnancy and Breastfeeding
It is not known if daridorexant can harm an unborn baby. Pregnant individuals should discuss the risks with their doctor. Breastfeeding is not recommended while using daridorexant and for at least one day after the last dose.
Drug Interactions
Daridorexant may interact with other medications, including those that cause drowsiness, opioid medications, muscle relaxers, and medicines for anxiety or seizures. It is important to inform your doctor about all other medications you are taking, including over-the-counter drugs, vitamins, and herbal products.
Conclusion
Daridorexant (Quviviq) is an FDA-approved medication for treating insomnia in adults. Approved on January 7, 2022, it helps individuals fall asleep and stay asleep by blocking the activity of the orexin protein. While it is generally well-tolerated, it can cause side effects and has several precautions and potential drug interactions that need to be considered. Always follow your doctor's instructions and consult them with any concerns or questions regarding the use of daridorexant.
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