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What is Dayvigo, and how does it work?
- Dayvigo is a prescription medicine for adults who have trouble falling or staying asleep (insomnia).
- It is not known if Dayvigo is safe and effective in children under the age of 18 years.
Dayvigo is a federally controlled substance (CIV) because it can be abused or cause dependence. Keep Dayvigo in a safe place to prevent misuse and abuse. Selling or giving away Dayvigo may harm others and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs.
What are the side effects of Dayvigo?
Dayvigo may cause serious side effects, including:
- 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 Dayvigo. 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 Dayvigo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Does Dayvigo cause addiction or withdrawal symptoms?
Drug Abuse And Dependence
Dayvigo contains lemborexant, a Schedule IV controlled substance.
- Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
- In a human abuse potential study conducted in recreational sedative abusers (n=29), lemborexant 10 mg, 20 mg (two times the maximum recommended dose), and 30 mg (three times the maximum recommended dose) produced responses on positive subjective measures such as “Drug Liking,” “Overall Drug Liking,” “Take Drug Again,” and “Good Drug Effects” that were statistically similar to those produced by the sedatives zolpidem (30 mg) and suvorexant (40 mg), and statistically greater than the responses on these measures that were produced by placebo.
- Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to Dayvigo, follow such patients carefully.
- Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
- In animal studies and clinical trials evaluating physical dependence, chronic administration of lemborexant did not produce withdrawal signs or symptoms upon drug discontinuation. This suggests that lemborexant does not produce physical dependence.
What is the dosage for Dayvigo?
The recommended dosage 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 the maximum recommended dose of 10 mg based on clinical response and tolerability. Time to sleep onset may be delayed if taken with or soon after a meal.
Dosage Recommendations For Concomitant Use With CYP3A Inhibitors Or CYP3A Inducers
Co-Administration With Strong Or Moderate CYP3A Inhibitors
- Avoid concomitant use of Dayvigo with strong or moderate CYP3A inhibitors.
Co-Administration With Weak CYP3A Inhibitors
- The maximum recommended dosage of Dayvigo is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors.
Co-Administration With Strong Or Moderate CYP3A Inducers
- Avoid concomitant use of Dayvigo with strong or moderate CYP3A inducers.
Dosage Recommendations For Patients With Hepatic Impairment
- The maximum recommended dose of Dayvigo is 5 mg no more than once per night in patients with moderate hepatic impairment.
- Dayvigo is not recommended in patients with severe hepatic impairment.
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What drugs interact with Dayvigo?
Drugs Having Clinically Important Interactions With Dayvigo
Table 2: Clinically Important Drug Interactions with Dayvigo
|Effect of Other Drugs on Dayvigo Strong, Moderate, and Weak CYP3A Inhibitors|
|Clinical Impact:||Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and Cmax which may increase the risk of Dayvigo adverse reactions.|
Avoid concomitant use of Dayvigo with strong or moderate CYP3A inhibitors.|
The maximum recommended dose of Dayvigo with weak CYP3A inhibitors is 5 mg.
|Examples:||Strong CYP3A inhibitors: itraconazole, clarithromycin|
Moderate CYP3A inhibitors: fluconazole, verapamil
Weak CYP3A inhibitors: chlorzoxazone, ranitidine
|Strong and Moderate CYP3A Inducers|
|Clinical Impact:||Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce Dayvigo efficacy.|
|Intervention:||Avoid concomitant use of Dayvigo with strong or moderate CYP3A inducers.|
|Examples:||Strong CYP3A inducers: rifampin, carbamazepine, St. John’s wort Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil|
|Clinical Impact:||Concomitant use of alcohol increases lemborexant Cmax and AUC. Co-administration of Dayvigo with alcohol produced a numerically greater negative impact on postural stability and memory as compared with alcohol alone when assessed near the tmax of Dayvigo (2 hours post-dose).|
|Intervention:||Avoid alcohol consumption with Dayvigo.|
Dayvigo on Other Drugs|
|Clinical Impact:||Concomitant use of Dayvigo decreases the AUC of drugs that are CYP2B6 substrates, which may result in reduced efficacy for these concomitant medications.|
|Intervention:||Patients receiving Dayvigo and CYP2B6 substrates concurrently should be monitored for adequate clinical response. Increasing the doses of CYP2B6 substrates may be considered as needed.|
Is Dayvigo safe to use while pregnant or breastfeeding?
- There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to Dayvigo during pregnancy.
- Healthcare providers are encouraged to register patients in the Dayvigo pregnancy registry by calling 1-888-274-2378.
- There are no data on the presence of lemborexant in human milk, the effects on the breastfed infant, or the effects on milk production. Lemborexant and its metabolites are present in the milk of lactating rats.
- When a drug is present in animal milk, it is likely that the drug will be present in human milk.
- Infants exposed to Dayvigo through breastmilk should be monitored for excessive sedation.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dayvigo and any potential adverse effects on the breastfed infant from Dayvigo or from the underlying maternal condition.
Dayvigo is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). Dayvigo is a federally controlled substance (CIV) because it can be abused or cause dependence. Serious side effects can include temporary inability to move or talk (sleep paralysis), temporary weakness in your legs, complex sleep behaviors during sleep (sleepwalking, sleep driving, eating or preparing food, or sex), and worsening depression and suicidal thoughts.
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Second Source article from Government
Sleep: A Dynamic Activity
Second Source article from Government
Sleep apnea is defined as a reduction or cessation of breathing during sleep. The three types of sleep apnea are central apnea, obstructive apnea (OSA), and a mixture of central and obstructive apnea. Central sleep apnea is caused by a failure of the brain to activate the muscles of breathing during sleep. OSA is caused by the collapse of the airway during sleep. OSA is diagnosed and evaluated through patient history, physical examination and polysomnography. There are many complications related to obstructive sleep apnea. Treatments are surgical and non-surgical.
Sleep Disorders (How to Get a Good Night's Sleep)
A number of vital tasks carried out during sleep help maintain good health and enable people to function at their best. Sleep needs vary from individual to individual and change throughout your life. The National Institutes of Health recommend about 7-9 hours of sleep each night for older, school-aged children, teens, and most average adults; 10-12 for preschool-aged children; and 16-18 hours for newborns. There are two stages of sleep; 1) REM sleep (rapid-eye movement), and 2) NREM sleep (non-rapid-eye movement). The side effects of lack of sleep or insomnia include: Irritability Tiredness Feeling sleepy during the day Concentration or memory problems Lack of sleep and insomnia can be caused by medical conditions or diseases, medications, stress, or pain. The treatment for lack of sleep and insomnia depends upon the cause.
Insomnia Treatment (Sleep Aids and Stimulants)
Insomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Insomnia is a symptom and not a disease. The most common causes of insomnia are medications, psychological conditions, environmental changes and stressful events. Treatments may include non-drug treatments, over-the-counter medicines, and/or prescription medications.
Sleepwalking (Causes, Symptoms, Treatment)
Sleepwalking is a condition in which an individual walks or does other activities while asleep. Factors associated with sleepwalking include genetic, environmental, and physiological. Episodes of sleepwalking may include quiet walking to agitated running. Conditions that may have similar symptoms of sleepwalking, but are not include night terrors, confusional arousals, and nocturnal seizures. Treatment of sleepwalking generally include preventative measures. Medication may be prescribed if necessary.
Sleep Related Breathing Disorders
Sleep-related breathing disorders are characterized by disruptions of normal breathing patterns that only occur during sleep. Snoring and sleep apnea are the most common sleep-related breathing disorders.
Insomnia (Symptoms, Causes, Remedies, and Cures)
Insomnia is the perception or complaint of inadequate or poor-quality sleep because of difficulty falling asleep; waking up frequently during the night with difficulty returning to sleep; waking up too early in the morning; or unrefreshing sleep. Secondary insomnia is the most common type of insomnia. Treatment for insomnia include lifestyle changes, cognitive behavioral therapy, and medication.
When sleepiness interferes with daily routines and activities, or reduces the ability to function, it is called "problem sleepiness." A person can have problem sleepiness without realizing it. Symptoms of problem sleepiness include: consistently don't get enough sleep, or poor quality sleep, fall asleep while driving, struggle to stay awake when inactive (like watching TV or reading), have difficulty paying attention or concentrating at work, school, or home, have poor performance problems at work or school, have difficulty remembering things, have slowed responses, have difficulty controlling your emotions, and/or if you have to take naps on most days.
Sleep and Sleep Disorders in Children and Teenagers
Sleep needs in children and teenagers depend on the age of the child. Sleep disorders in children such as: sleep apnea, parasomnias, confusional arousals, night terrors, nightmares, narcolepsy, and sleepwalking which can affect a child's or teen's sleep. Healthy sleep habits and good sleep hygiene can help your infant, toddler, preschooler, tween, or teenager get a good night's sleep.
Sleep paralysis is a condition that causes a person to feel as if he or she is awake but is unable to move. Lack of sleep, sleep disorders, use of certain medications, and other factors may be related to sleep paralysis. Sleep paralysis usually does not require treatment; however, treating underlying conditions may help sleep paralysis.
What Are the Three Types of Insomnia?
Insomnia is defined as repeated difficulty with sleep initiation, maintenance, consolidation, or quality that occurs despite adequate time and opportunity for sleep and results in some form of daytime impairment. There are three types of insomnia.
What Are the Warning Signs of Sleep Apnea?
Sleep apnea is a serious sleep disorder in which an individual’s breathing frequently stops during sleep. The inadequate breathing causes oxygen levels in the blood to drop and disturb sleep.
Do You Hallucinate During Sleep Paralysis?
Some people may experience hallucinations during sleep paralysis. The hallucinations may last from a few seconds to a few minutes.
Why Am I Having Trouble Sleeping at Night?
Having repeated difficulty with sleep initiation, maintenance or poor quality of sleep that occurs despite adequate time and opportunity for sleep, resulting in some form of daytime impairment is called insomnia.
What Are the Five Types of Insomnia?
The five types of insomnia are as follows: acute insomnia, chronic insomnia, onset insomnia, maintenance insomnia, and behavioral insomnia of childhood.
What Are the Warning Signs of Sleep Apnea?
Sleep apnea is a sleep disorder that can potentially lead to serious systemic health complications. It is a condition that causes a person to intermittently stop breathing during sleep. Warning signs of sleep apnea include snoring, nighttime gasping, intermittent pauses during sleep, and daytime sleepiness.
What Are the Three Types of Sleep Apnea?
Sleep apnea is a sleep disorder that can potentially lead to serious health complications. In sleep apnea, the person may stop breathing for some time during sleep. The three kinds of sleep apnea are obstructive sleep apnea, central sleep apnea, and mixed sleep apnea.
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