Contents

RAMELTEON Tablets 8mg [SAWAI] is a new category of insomnia treatment known as a melatonin receptor agonist. Its mechanism of action differs from conventional sleeping pills. Instead of producing sedation or anti-anxiety effects, it helps restore the body’s natural sleep rhythm and promotes more natural sleep.

Because it does not have a direct sedative effect, the effectiveness may vary among individuals. It may not be suitable for severe chronic insomnia with a long treatment history or insomnia associated with psychiatric conditions such as depression.

Compared with benzodiazepine sleep medications, this medicine is associated with a lower risk of side effects such as unsteadiness and memory impairment. It is also less likely to cause rebound insomnia or withdrawal symptoms after discontinuation, and it has no known drug dependence potential.

As of May 20, 2026, the designation as a prescription-only medicine in Japan has been removed.

Efficacy

Ramelteon works on melatonin receptors, which are deeply involved in regulating the sleep-wake cycle. By adjusting the body’s natural rhythm of sleep and wakefulness, it helps prepare the brain and body for sleep.

It is usually used to improve difficulty falling asleep associated with insomnia.

This medicine supports the body’s natural sleep rhythm and promotes natural sleep onset. It is generally considered suitable for relatively mild chronic insomnia, especially in patients without extensive prior treatment history. It may also be beneficial for sleep difficulties related to irregular lifestyle patterns or disrupted sleep schedules.

Usage

Usually, adults take 1 tablet (8mg of ramelteon) once daily before bedtime. Follow the instructions provided by your physician or pharmacist.

Do not take this medicine together with food or immediately after meals.
Do not take it if you may need to wake up during sleep to perform activities.
If you miss a dose and wake up during the night unable to sleep, you may take one dose only if there is sufficient time remaining before your planned wake-up time. Otherwise, drowsiness or unsteadiness may remain the next morning.
Never take two doses at once.
If you accidentally take more than the prescribed dose, consult your doctor or pharmacist immediately.
Do not stop taking this medicine without medical advice.

Internal capacity

100 tablets per box

＜Warning＞

Consult your doctor or pharmacist before use if you:

Have previously experienced allergic reactions such as itching or rash caused by medicines or foods
Have liver dysfunction, sleep apnea syndrome, or organic brain disorders
Are pregnant or breastfeeding
Are using other medicines, supplements, or foods that may interact with this product

Precautions

This medicine may cause drowsiness, reduced attention, impaired concentration, or decreased reflex ability the following morning. Do not drive or operate hazardous machinery after taking it.
Alcohol may increase the effects of this medicine. Avoid drinking alcohol while using this product.
Breastfeeding should be discontinued while taking this medicine.

Possible Side Effects

Reported side effects include:

Dizziness
Headache
Drowsiness
Rash
Constipation
Nausea
Fatigue

If any of these symptoms occur, consult your doctor or pharmacist.

In rare cases, serious allergic reactions may occur. Stop using the medicine immediately and seek medical attention if you experience symptoms such as: