Is Gocovri (amantadine) better taken at bedtime or in the morning?

From the Guidelines

Gocovri (amantadine extended-release) should be taken at bedtime, typically 1-2 hours before sleep, as this timing recommendation is designed to maximize the medication's effectiveness for Parkinson's disease patients with dyskinesia or OFF episodes. Taking Gocovri at night allows the medication to reach peak levels in the morning when Parkinson's symptoms are often most troublesome. The extended-release formulation works throughout the night, providing therapeutic levels upon waking and throughout the day.

Key Considerations

• Morning administration is not recommended because it could lead to sleep disturbances, as amantadine can cause insomnia as a side effect 1.
• Additionally, taking Gocovri with food is not necessary, but the capsules should be swallowed whole without crushing, chewing, or opening them to maintain the extended-release properties.
• If a dose is missed, patients should skip that dose and resume the regular schedule the following evening rather than taking a double dose.

Side Effects and Precautions

• Side effects associated with amantadine are usually mild and cease soon after discontinuing the drug, but serious side effects have been observed, including marked behavioral changes, delirium, hallucinations, agitation, and seizures 1.
• These more severe side effects have been associated with high plasma drug concentrations and have been observed most often among persons who have renal insufficiency, seizure disorders, or certain psychiatric disorders and among older persons who have been taking amantadine as prophylaxis at a dosage of 200 mg/day.
• Clinical observations and studies have indicated that lowering the dosage of amantadine among these persons reduces the incidence and severity of such side effects.

Administration and Dosage

• The recommended dosage of Gocovri is based on the patient's response and tolerance, and it is essential to follow the prescribed dosage and administration schedule to minimize the risk of side effects and maximize the medication's effectiveness.
• Patients should be monitored closely for signs of side effects, and the dosage should be adjusted as needed to achieve the optimal therapeutic response.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Administration Timing of Gocovri

• Gocovri is recommended to be taken once daily at bedtime, as stated in the studies 2, 3, 4.
• The extended-release formulation of amantadine allows for a more gradual time to peak plasma concentration and higher drug concentrations in the morning and throughout the day, which is when levodopa-induced dyskinesia is most problematic 3.
• There is no evidence to suggest that Gocovri should be administered in the mornings instead of at bedtime.

Efficacy and Safety of Gocovri

• Gocovri has been shown to be effective in reducing dyskinesia and improving motor symptoms in patients with Parkinson's disease 2, 3, 5.
• The most common adverse events associated with Gocovri include hallucinations, dizziness, dry mouth, and peripheral edema 2, 3, 6, 4.
• Gocovri has been generally well tolerated, with most adverse events being transient and mild or moderate in severity 3, 4.

Clinical Trials and Studies

• The EASE LID 2 study, a 2-year open-label trial, evaluated the long-term safety, tolerability, and efficacy of Gocovri in patients with Parkinson's disease experiencing levodopa-induced dyskinesia 2.
• The EASE LID and EASE LID 3 trials, randomized, double-blind phase III trials, demonstrated the efficacy and safety of Gocovri in reducing dyskinesia and improving motor symptoms 3, 5.
• The EASED study, a randomized, double-blind, placebo-controlled, parallel-group study, investigated the safety, efficacy, and tolerability of ADS-5102, a long-acting, extended-release capsule formulation of amantadine HCl, in Parkinson's disease patients with levodopa-induced dyskinesia 4.