莱博雷生(Dayvigo)的详细说明书:适应症、用法用量、副作用及注意事项等

Dayvigo was developed by Eisai of Japan. In 2019, it was the first to be approved for marketing by the US FDA, and was subsequently launched in more than ten countries including Japan and Australia. In 2025, it will be officially launched in China.

Indications of Dayvigo

Insomnia

(1) Treatment of insomnia characterized by difficulty falling asleep and/or maintaining sleep.

(2) It can shorten the sleep latency and improve sleep maintenance.

The above content comes from the official website of drugs. It only reflects the scope of indications in the countries where the drug is registered overseas. It does not represent the scope of approved use in mainland China. Please do not make any treatment decisions based on this.

Dayvigo usage and dosage

1. Pre-treatment screening

Because sleep disorders may be a manifestation of physical and/or mental illness, symptomatic treatment for insomnia can only be initiated after careful patient evaluation.

2. Method of administration

(1) Oral administration

Take it at most once a night, and should take it just before going to bed.

(2) Taking on an empty stomach

Taking it with a meal or shortly after a meal may delay the onset of drug effects.

(3) Guaranteed sleep time

Only used when at least 7 hours away from the planned wake-up time.

3. Common dosage for adults

Take 5mg before bed, once a day. May be increased to a maximum of 10 mg nightly, once daily, based on clinical response and tolerability.

4. Dosage for special groups

(1) Hepatic insufficiency

Moderate hepatic insufficiency: The recommended maximum dose is 5 mg every night, once a day.

Severe hepatic insufficiency: Not recommended.

(2) Renal insufficiency

No dose adjustment is required.

(3) Elderly patients

For patients aged 65 years and above, caution should be used when using doses exceeding 5 mg.

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The above content comes from the official website of drugs. It only reflects the usage and dosage range of the drug in overseas registered countries. It does not represent the approved use range in mainland China. Please do not make any treatment decisions based on this.

Common adverse reactions of Dayvigo

Drowsiness.

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The above content is from the drugs official website. It only reflects the range of side effects of the drug in overseas registered countries and does not represent the approved use range in mainland China. Please do not make any treatment decisions based on this.

Precautions for Dayvigo

1. Central nervous system depressant effect, nighttime safety and impairment of daytime function

Dayvigo is a central nervous system depressant and may impair daytime wakefulness even if used as prescribed. May increase risk of falls, especially in older patients. May affect driving ability. The effects may last for up to several days after you stop taking the drug.

The risk of impaired daytime functioning is increased if taken less than a full night before waking, in excess of the recommended dose, or with other CNS depressants.

2. Sleep paralysis, pre-sleep/pre-awake hallucinations and cataplexy-like symptoms

Sleep paralysis (the inability to move or speak for several minutes during the transition from sleep to wake-up) and pre-sleep/pre-wake hallucinations have been reported. Symptoms resembling mild cataplexy (eg, leg weakness, lasting seconds to minutes) may occur at night and/or during the day and may not be associated with a clear triggering event (eg, laughter, surprise).

3. Complex sleep behaviors

After using Dayvigo, there have been reports of complex sleep behaviors, including sleepwalking, driving while sleeping, and other activities (such as preparing and eating food, making phone calls, and having sex) while not fully awake and without memory of the event. If complex sleep behaviors occur, Dayvigo should be discontinued immediately.

4. Patients with impaired respiratory function

If used in patients with impaired respiratory function, the possible impact on respiratory function should be considered.

5. Exacerbation of depression/suicidal ideation

A higher incidence of suicidal ideation has been observed in clinical studies. Exacerbations of depression and suicidal thoughts and behaviors, including completed suicide, have been reported in patients treated primarily with sedative-hypnotic medications for depression. Such patients may be suicidal and intentional overdose is more common. Protective measures may be required.

If a patient develops suicidal tendencies or any new behavioral abnormalities, the patient should be evaluated immediately.

6. Adequate patient assessment

Sleep disturbance may be a manifestation of underlying physical and/or mental illness, and patients should be carefully evaluated before symptomatic treatment for insomnia is initiated.

7. Abuse Potential and Dependence

Patients with a history of drug or alcohol abuse or addiction are at increased risk for abuse and addiction; use in such patients should only be done under careful monitoring. In clinical studies, no rebound insomnia or withdrawal effects were observed after discontinuation of the drug.

Special groups of Dayvigo

1. Pregnancy period

There is no sufficient human data. In animal reproduction studies, developmental toxicity and maternal toxicity were observed only at exposures well above the maximum recommended human dose.

2. Lactation period

Dayvigo and its metabolites will be distributed into the milk of rats; it is unclear whether they will be distributed into human milk. The effects on milk production or breastfed infants are also unknown.

The benefits of breastfeeding need to be weighed against the importance of the drug to the woman, against the potential adverse effects of the drug or underlying maternal disease on the breastfed infant.

3. Pediatric use

The safety and effectiveness in pediatric patients have not been established.

4. Elderly use

There is no overall difference in efficacy compared with young adults; however, the incidence of drowsiness in elderly patients who received the 10 mg dose was higher than that in young adults.

Older patients are at particularly high risk for falls. In patients 65 years of age and older, caution should be used when using doses above 5 mg.

5. Hepatic insufficiency

Mild hepatic insufficiency (Child-Pugh Class A): No dose adjustment is required; however, the risk of drowsiness may increase in such patients.

Moderate hepatic impairment (Child-Pugh class B): The initial and maximum dose of leborexan is 5 mg nightly, once daily.

Severe hepatic insufficiency: Not studied yet; not recommended.

6. Renal insufficiency

No dose adjustment of Dayvigo is required. Patients with severe renal insufficiency may be at increased risk for somnolence.

Dayvigo drug interactions

1. Drugs that affect liver microsomal enzymes

CYP3A inhibitors: may increase the plasma concentration and adverse reactions of Dayvigo. Avoid coadministration with strong or moderate CYP3A inhibitors. If used concomitantly with a weak CYP3A inhibitor, the recommended maximum dose of Dayvigo is 5 mg nightly once daily.

CYP3A inducers: may reduce the systemic exposure and efficacy of Dayvigo. Avoid coadministration with strong or moderate CYP3A inducers.

2. Drugs metabolized by hepatic microsomal enzymes

CYP2B6 substrates: may reduce the systemic exposure and efficacy of CYP2B6 substrates. If used together, consider increasing the dose of the CYP2B6 substrate if necessary.

CYP2C8, CYP2C9 or CYP2C19 substrates: Based on physiological pharmacokinetic models, Dayvigo is expected to have minimal impact on the pharmacokinetics of these substrate drugs.

3. Specific drugs

Azole antifungals (fluconazole, itraconazole), bosentan, bupropion, carbamazepine, chlorzoxazone, clarithromycin, central nervous system depressants (such as alcohol, benzodiazepines, opioids, tricyclic antidepressants, other hypnotics), efavirenz, etretin Verinine, famotidine, midazolam, modafinil, oral contraceptives, opioids (such as methadone), ranitidine, rifampicin, St. John's wort, verapamil, etc., may decrease or increase the systemic exposure and efficacy of leborexan (Dayvigo).
Note: If you want to know more details, please check the original package insert of the drug. Please follow the doctor's instructions for specific medication.