Dayvigo
Generic name: lemborexant
Dosage form: oral tablet
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics
What is Dayvigo?
Dayvigo (lemborexant) is a sleeping pill that helps people who have trouble falling or staying asleep to sleep better. It helps you fall asleep faster and stay asleep for longer.
Dayvigo belongs to a class of drugs known as orexin antagonists. Dayvigo works by blocking orexin receptors (OX1R and OX2R), which prevents orexin A and B from binding to them. Orexin A and B are part of the orexin neuropeptide signaling system and one of their roles is to promote wakefulness. Blocking them from their receptor binding sites is thought to help suppress the urge to wake up. This class of drugs works differently from benzodiazepines which have been used to treat insomnia for many years.
Dayvigo is a schedule IV federally controlled substance (CIV) because it can be abused or cause dependence. Selling or giving away Dayvigo may harm others and is against the law.
Dayvigo was first approved by the US Food and Drug Administration in 2019.
What is Dayvigo used for?
Dayvigo is a prescription medicine used to treat adults who have trouble falling or staying asleep (insomnia).
It is not known if this medication is safe and effective in children under the age of 18 years.
Important information
Dayvigo may cause serious side effects including:
- Decreased awareness and alertness. The morning after you take this medication, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.
- Do not take more than prescribed.
- Do not take unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again.
- Take right before going to bed.
See “What are the possible side effects of Dayvigo?” below for more information about side effects.
Who should not take Dayvigo?
Do not take Dayvigo if you fall asleep often at unexpected times (narcolepsy).
What should I tell my doctor before taking Dayvigo?
Before taking Dayvigo, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of depression, mental illness, or suicidal thoughts.
- have a history of drug or alcohol abuse or addiction.
- have a history of a sudden onset of muscle weakness (cataplexy).
- have a history of daytime sleepiness.
- have lung problems or breathing problems, including sleep apnea.
- have liver problems.
How should I take Dayvigo?
- Take Dayvigo exactly as your healthcare provider tells you to take it.
- Only take one time each night, right before going to bed.
- Only take when you can stay in bed for a full night (at least 7 hours).
- Dayvigo may take longer to work if you take it with or soon after a meal.
- Do not increase your dose without talking to your healthcare provider first. Call your healthcare provider if your insomnia (sleep problem) worsens or is not improved within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
What happens if I miss a dose?
If you forget to take your dose of Dayvigo right before going to bed, skip that dose unless you can still stay in bed for at least 7 hours (a full nights sleep) after taking it. If you do not remember in time, wait until your next dose is due the following night. Do not take a double dose if you miss a dose.
What happens if I overdose?
If you take too much Dayvigo, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking Dayvigo?
- Do not drink alcohol while taking Dayvigo. It can increase your chances of getting serious side effects.
- Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you take Dayvigo and have had less than a full night of sleep (at least 7 hours) or if you have taken more than prescribed by your healthcare provider.
- You may still feel drowsy the next day after taking this medication. Do not drive or do other dangerous activities until you feel fully awake.
Dosing information
The recommended dose of Dayvigo is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to 10 mg per night if required.
In patients with moderate liver/hepatic impairment the maximum dose of Dayvigo is 5 mg. This medication is not recommended in patients with severe hepatic impairment.
See Full Prescribing Information for further details about Dayvigo dosing.
What are the side effects of Dayvigo?
Dayvigo may cause serious side effects, including:
- see “Important information" above
- temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up.
- temporary weakness in your legs that can happen during the day or at night.
- complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Call your healthcare provider right away if you experience a complex sleep behavior.
- worsening depression and suicidal thoughts have happened during treatment with this medication. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
The most common side effect of Dayvigo is sleepiness.
These are not all of the possible side effects of this medication. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Interactions
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Taking Dayvigo with certain other medicines can cause serious side effects. Dayvigo may affect the way other medicines work and other medicines may affect the way this medication works.
Do not take with other medicines that can make you sleepy unless your healthcare provider tells you to.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
Pregnancy and breastfeeding
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Dayvigo can harm your unborn baby.
There is a pregnancy registry for women who are exposed to Dayvigo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. For more information or to participate in the registry, call 1-888-274-2378. Talk with your healthcare provider about the risk to your unborn baby if you take this medication during pregnancy.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Dayvigo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.
Storage
- Store Dayvigo at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep out of the reach of children.
What are the ingredients in Dayvigo?
Active ingredient: lemborexant
Inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. The tablet film coating contains: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either ferric oxide yellow for the 5 mg tablet; or both ferric oxide yellow and ferric oxide red for the 10 mg tablet.
Dayvigo is distributed by Eisai Inc. Nutley, NJ 07110.
Popular FAQ
Yes, Dayvigo contains lemborexant, a Schedule IV controlled substance and may cause sleepiness. People with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to Dayvigo. Do not drink alcohol while taking Dayvigo due to the risk of serious side effects. Keep this medicine in a safe place to prevent misuse, abuse or theft. Selling or giving away Dayvigo to others may be harmful and is against the law.
No, you should not drink alcohol while tasking Dayvigo because it can increase the side effects of Dayvigo such as drowsiness, dizziness, affect judgment, or impair memory or comprehension.
Yes, Dayvigo is a medication to help you fall asleep faster and stay asleep longer. In Phase III clinical studies at 6 months time, Dayvigo sleep medication (5 and 10 mg tablets) helped people fall asleep faster by about 7 to 8 minutes more than a placebo, an inactive agent (results: Dayvigo 5 mg = 20 min; Dayvigo 10 mg = 19.2 min; placebo = 27.2 min).
Yes, you can access a 10-day Dayvigo free trial by printing a voucher from the Eisai Inc. website. Take the voucher along with your prescription to the pharmacist. The manufacturer also offers an Instant Savings Card that can bring your prescription costs down to as little as $30 per month.
Dayvigo starts to work right away to help you fall asleep and stay asleep. In 6-month long studies, people fell asleep an average in about 20 minutes after taking their dose. Dayvigo may take longer to work if you take it with or soon after a meal. Because it works so quickly, only take your Dayvigo dose right before going to bed. Do not take Dayvigo unless you can stay in bed for at least 7 hours before you must be active again.
Dayvigo (lemborexant) is classified as a dual orexin receptor antagonist (DORA). It is approved for the treatment of adults with insomnia who have trouble falling asleep or staying asleep. Dayvigo works by blocking the wake-promoting neuropeptides orexin A and orexin B from attaching to their receptors in the hypothalamus of the brain. Orexin signals in the brain are thought to play a role in wakefulness.
Dayvigo has not been shown to cause weight gain in studies conducted by the manufacturer. The most common side effect of Dayvigo is sleepiness. Other reported side effects include headache, abnormal dreams and sleep paralysis. Dayvigo is prescribed to help adults who have trouble falling or staying asleep (insomnia).
Dayvigo may be addictive in some people, particularly those with a history of drug or alcohol addiction, or in those who take more than the recommended dose. Continue reading
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