Treatment for insomnia with daridorexant (difficulty falling asleep or staying asleep). Orexin receptor antagonists are a group of drugs that includes daridorexant. It functions by inhibiting a specific natural substance’s ability to awaken the brain.

Daridorexant is available as an oral tablet. If necessary, it is typically taken once daily, no sooner than 30 minutes prior to night. Daridorexant can be taken with or without meals, however it starts working more quickly when taken without food. Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. Do not alter the dosage of your daridorexant. Even if you still have difficulties falling or staying asleep, never take more than one dose of daridorexant each day.

Just after taking daridorexant, you’ll undoubtedly feel extremely tired and likely stay that way for a while. After taking the drug, schedule a sleep period of at least seven hours. If you won’t be able to sleep for the required number of hours after taking the drug, avoid taking daridorexant. After taking daridorexant, if you get up too quickly, you can feel sleepy and have trouble driving or doing other duties that call for attentiveness.

If you begin using daridorexant, your sleep issues should start to improve within 7 to 10 days. If your sleep issues do not improve during this period or if they worsen at any point while you are receiving therapy, call your doctor.

Do not split, chew, or crush the tablets or capsules; instead, swallow them whole.

Daridorexant may lead to habit formation. Don’t take the medication in excess of what your doctor has suggested in terms of dosage, frequency, or duration.

You will receive the manufacturer’s patient information leaflet (Medication Guide) from your doctor or chemist when you start taking daridorexant and each time you refill your prescription. If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

Before taking daridorexant,

• If you have an allergy to daridorexant, any other drugs, or any of the substances in daridorexant tablet, inform your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
• Inform your doctor and chemist about any other prescription and over-the-counter drugs, vitamins, and dietary supplements you are now taking or intend to take. Incorporate any of the following: Amitriptyline, amoxapine, aprepitant (Emend), alprazolam (Xanax), and atazanavir (Reyataz), clarithromycin (Biaxin, in Prevpac), boceprevir (Victrelis), carbamazepine (Carbatrol, Equetro), chlordiazepoxide (Librium), clobazam (Onfi, Sympazan), clomipramine (Anafranil), and clonazepam (Klonopin), hydromorphone, fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Subsys), fosamprenavir (Lexiva), diltiazem (Cardizem, Tiazac), diazepam (Valium), diltiazem (Cardizem, Tiazac), doxepin (Silenor), erythromycin (E.E.S (Dilaudid), midazolam (Versed), morphine (Arymo ER, Kadian, Morphabond, MS Contin, in Embeda), nefazodone, nelfinavir (Viracept), nortriptyline, indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole, nefazodone, and nortriptyline (Pamelor), protriptyline (Vivactil), oxycodone (Oxaydo, Xtampza ER), oxymorphone (Opana), phenytoin (Dilantin, Phenytek), posaconazole (Noxafil), rifampin (Rifadin, Rimactane), ritonavir (Norvir, in Kaletra), and saquinavir are some examples of (Invirase), temazepam (Restoril), triazolam (Halcion), trimipramine (Surmontil), telaprevir (Incivek), telithromycin (Ketek), and verapamil (Verelan, Covera). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all of the medications you are taking, even any not on this list, since many other drugs may also interact with daridorexant.
• Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
• If you have narcolepsy, let your doctor know. Most likely, your doctor will advise against taking dariorexant.
• Inform your physician if you currently use or have previously used excessive amounts of street drugs, alcohol, or prescription medications. Tell your doctor if you have or have ever had depression, mental illness, suicidal thoughts or attempts, chronic obstructive pulmonary disease (COPD), a group of diseases that affect the lungs and airways, sleep apnea, any other lung or breathing issues, sudden muscle weakness, liver disease, or any other conditions that affect breathing or the lungs.
• Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you become pregnant while using dariorexant.
• You should let your doctor or dentist know that you are taking daridorexant if you are having surgery, including dental surgery.
• You should be aware that the day after taking daridorexant, these side effects may cause tiredness, decreased mental alertness, and issues with coordination. These symptoms may last for several days after quitting the medicine. In particular if you are senior, this could raise your chance of significant injury-causing falls. Daridorexant may potentially impair your ability to drive and raise your chance of dozing off behind the wheel. Even if you feel fully awake the day after taking daridorexant, it’s possible that you won’t be able to drive or operate machinery. Within seven hours of taking daridorexant and until you feel fully awake, avoid driving, using machinery, and engaging in any other risky activities. If you plan to drive or operate machinery after taking dariorexant, discuss the dangers with your doctor.
• While taking dariorexant, avoid drinking alcohol. Daridorexant adverse effects can be exacerbated by alcohol.
• You should be aware that some users of daridorexant got out of bed to drive, cook, prepare, and consume food, engage in sex, make calls, or engage in other activities while only partially awake. These people frequently had no memory of what they had done when they awoke. If you discover that you were driving or engaging in any other strange behaviour while you were asleep, call your doctor straight once.
• You should be aware that while taking this medicine, your behaviour and mental health may alter in unanticipated ways. Daridorexant, physical or mental problems you already have or develop as a result of treatment, or both may contribute to these changes. Any of the following symptoms should be reported to your doctor right away: aggression, strange or unusually outgoing behaviour, hallucinations (seeing things or hearing voices that are not there), feeling as though you are outside of your body, memory issues, anxiety, new or worsening depression, considering suicide or trying to commit suicide, confusion, and any other changes in your regular thoughts, mood, or behaviour. Make sure your family is aware of any potentially critical symptoms so they can contact the doctor on your behalf if you are unable to get help on your own.

Keep eating normally unless your doctor instructs you otherwise.

Typically, this drug is given as needed. If you will be able to stay in bed for the required number of hours after taking daridorexant, you may take it even if it is later than normal.

Daridorexant might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Headache
• Fatigue
• Daytime slumber
• Dizziness
• Nausea

Certain adverse effects can be very harmful. Call your doctor right away if you have any of the following signs or symptoms:

• Brief incapacity to speak or move during falling asleep or waking up, lasting up to several minutes
• During falling asleep or waking up, hallucinations (seeing things or hearing voices that aren’t there) might occur
• Momentary nighttime or daytime leg weakness

Other negative effects of daridorexant may occur. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

• Weariness, weakening in the muscles, headaches, concentration problems, constipation, loss of voluntary muscle control, and the inability to speak or move

Keep all of your doctor’s appointments.

No one else should take your medication. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.