Contents
- 1 Dayvigo (lemborexant)
- 1.0.1 What are the side effects of Dayvigo?
- 1.0.2 Does Dayvigo cause addiction or withdrawal symptoms?
- 1.0.3 What is the dosage for Dayvigo?
- 1.0.4 What drugs interact with Dayvigo?
- 1.0.5 Is Dayvigo safe to use while pregnant or breastfeeding?
- 1.0.6 Subscribe to MedicineNet’s Depression Newsletter
- 1.0.7 Summary
Dayvigo (lemborexant)
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 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 the FDA at 1-800-FDA-1088.
Does Dayvigo cause addiction or withdrawal symptoms?
Drug Abuse And Dependence
Controlled Substance
Dayvigo contains lemborexant, a Schedule IV controlled substance.
Abuse
- Abuse is the intentional, non-therapeutic use of a drug for its desired effects.
- In a study conducted in recreational sedative abusers, lemborexant produced responses on positive subjective measures similar to those produced by other sedatives and greater than those produced by a placebo.
- Follow patients with a history of abuse or addiction carefully.
Dependence
- Physical dependence is a state that develops as a result of repeated drug use, manifested by withdrawal signs and symptoms after discontinuation or dose reduction.
- In studies, chronic administration of lemborexant did not produce withdrawal signs or symptoms.
What is the dosage for Dayvigo?
Dosing Information
The recommended dosage of Dayvigo is 5 mg taken 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 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 in patients with moderate hepatic impairment.
- Dayvigo is not recommended in patients with severe hepatic impairment.
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 CYP3A inhibitor increases lemborexant exposure which may increase the risk of Dayvigo adverse reactions. |
| Intervention: | Avoid concomitant use of Dayvigo with 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 CYP3A inducer decreases lemborexant exposure, which may reduce Dayvigo efficacy. |
| Intervention: | Avoid concomitant use of Dayvigo with CYP3A inducers. |
| Examples: | Strong CYP3A inducers: rifampin, carbamazepine, St. John’s wort | Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil |
| Alcohol | |
| Clinical Impact: | Concomitant use of alcohol increases lemborexant exposure. Co-administration of Dayvigo with alcohol produced a greater negative impact on postural stability and memory compared with alcohol alone. |
| Intervention: | Avoid alcohol consumption with Dayvigo. |
| Effect of Dayvigo on Other Drugs CYP2B6 Substrates | |
| Clinical Impact: | Concomitant use of Dayvigo decreases the exposure of drugs that are CYP2B6 substrates, which may result in reduced efficacy. |
| Intervention: | Monitor patients receiving Dayvigo and CYP2B6 substrates concurrently. Increasing the doses of CYP2B6 substrates may be considered as needed. |
| Examples: | Bupropion, methadone |
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.
- 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.
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Summary
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.
