What is the recommended treatment and dosage for insomnia using Ramelteon (melatonin receptor agonist)?

From the Guidelines

Ramelteon is recommended for insomnia characterized by difficulty falling asleep, with a standard dosage of 8 mg taken within 30 minutes before bedtime, as suggested by the American Academy of Sleep Medicine clinical practice guideline 1. The medication should not be taken after getting into bed or with or immediately after a high-fat meal, as this can reduce its effectiveness. Ramelteon works by selectively targeting melatonin receptors (specifically MT1 and MT2) in the brain's suprachiasmatic nucleus, which helps regulate the body's natural sleep-wake cycle. Some key points to consider when prescribing Ramelteon include:

• It is not a controlled substance, has minimal risk of dependence, and doesn't cause significant morning grogginess or rebound insomnia when discontinued, making it a safer option for older adults or those with a history of substance abuse concerns 1.
• Common side effects include dizziness, fatigue, and somnolence, and patients should avoid alcohol while taking Ramelteon and inform their doctor about all other medications they're taking, as certain drugs like fluvoxamine can significantly increase Ramelteon levels in the body 1.
• The medication typically begins working within a week, though some patients may need to take it for longer to experience full benefits.
• The evidence for Ramelteon's effectiveness is based on trials of 8 mg doses, and it has been shown to improve sleep latency, although the overall quality of evidence is downgraded to very low due to substantial heterogeneity across studies, imprecision, and potential publication bias 1.

From the FDA Drug Label

The recommended dose of ramelteon tablets is 8 mg taken within 30 minutes of going to bed. The total ramelteon tablets dose should not exceed 8 mg per day.

The recommended treatment and dosage for insomnia using Ramelteon is 8 mg taken within 30 minutes of going to bed, with a maximum dose of 8 mg per day 2.

• The dose should not be taken with or immediately after a high-fat meal.
• Ramelteon tablets are not recommended in patients with severe hepatic impairment and should be used with caution in patients with moderate hepatic impairment.
• Ramelteon should not be used in combination with fluvoxamine and should be used with caution in patients taking other CYP1A2 inhibiting drugs.

From the Research

Recommended Treatment and Dosage for Insomnia using Ramelteon

• Ramelteon is a selective melatonin receptor (MT(1) and MT(2)) agonist approved by the US Food and Drug Administration for the treatment of insomnia characterized by difficulty with sleep onset 3, 4.
• The recommended dosage of Ramelteon is 8 mg, taken approximately 30 minutes prior to bedtime 3, 4.
• Ramelteon has been shown to improve latency to persistent sleep (LPS) and total sleep time (TST) in patients with chronic insomnia 4, 5.
• The medication is generally well tolerated, with common adverse events including headache, dizziness, somnolence, fatigue, and nausea 4, 5.
• Ramelteon does not impair next-day cognitive or motor performance and is not associated with withdrawal symptoms, rebound insomnia, or abuse potential 3, 4.

Efficacy of Ramelteon in Insomnia Treatment

• Studies have demonstrated that Ramelteon reduces subjective sleep latency (sSL) and improves sleep quality, with a modest but statistically significant effect 6.
• Ramelteon has also been associated with improvement in LPS, sleep efficiency (SE), and TST, although the clinical impact is small 6.
• Long-term trials are needed to establish the efficacy of Ramelteon in insomnia treatment 6.
• Ramelteon's efficacy appears to be relatively modest compared to current insomnia therapeutics, and its use seems restricted to patients with sleep onset difficulties 7.

Safety and Tolerability of Ramelteon

• Ramelteon is not classified as a controlled substance and has no abuse liability 3, 4.
• The medication is not associated with cognitive impairment, rebound insomnia, or withdrawal effects 4, 5.
• Common adverse events include somnolence, headache, dizziness, fatigue, and nausea, but Ramelteon is generally well tolerated 4, 5.