What is the recommended treatment and dosage for insomnia using Rozerum (ramelteon)?

Ramelteon (Rozerem) for Insomnia Treatment

Ramelteon 8 mg taken within 30 minutes of bedtime is recommended for the treatment of sleep onset insomnia in adults. 1

Dosage and Administration

• Standard dose: 8 mg orally once daily
• Timing: Take within 30 minutes of going to bed 1
• Administration considerations:
  • Do not take with or immediately after a high-fat meal
  • Total daily dose should not exceed 8 mg 1
  • No FDA limitations on duration of use 2

Clinical Indications

Ramelteon is specifically indicated for:

• Sleep onset insomnia (difficulty falling asleep) 3
• Not indicated for sleep maintenance insomnia 3

Mechanism of Action

Ramelteon works differently from other sleep medications:

• Selective melatonin receptor (MT1 and MT2) agonist 2
• Enhances sleep through effects on sleep regulatory mechanisms in the suprachiasmatic nucleus
• Does not have direct sedating effects like other hypnotics 2

Clinical Efficacy

• Reduces latency to persistent sleep (time to fall asleep) by approximately 9-19 minutes compared to placebo 1, 4
• Modest but statistically significant improvements in:
  • Sleep onset time
  • Total sleep time (increases of 8-22 minutes in some studies) 4
• Effects on sleep onset are evident at week 1 and can be sustained through 5 weeks of treatment 5

Special Populations

• Hepatic impairment:
  • Not recommended in severe hepatic impairment
  • Use with caution in moderate hepatic impairment 1
• Elderly patients:
  • Standard 8 mg dose is appropriate; no dose adjustment needed 1

Drug Interactions

• Contraindicated with:
  • Fluvoxamine (strong CYP1A2 inhibitor) 1
• Use with caution with:
  • Other CYP1A2 inhibitors 1

Safety Profile and Advantages

• No abuse potential:
  • Not classified as a controlled substance by DEA 2
  • No evidence of withdrawal symptoms or rebound insomnia 4, 5
• Common adverse effects:
  • Headache (7-19%)
  • Dizziness (5%)
  • Somnolence (5-8%)
  • Fatigue (4-9%)
  • Nausea (3%) 4, 5
• No significant impairment of next-day cognitive or motor performance 6

Clinical Pearls

• Ramelteon is the only FDA-approved sleep medication that works through melatonin receptors rather than through sedative effects 2
• Most appropriate for patients with difficulty falling asleep rather than staying asleep
• May be particularly valuable for patients with history of substance abuse or concerns about medication dependence 2
• Effects on sleep latency are modest but clinically meaningful for many patients 4

Monitoring

• Assess effectiveness based on improvement in sleep onset time
• Monitor for adverse effects, particularly headache and dizziness
• No specific laboratory monitoring required

Bold text indicates the most important recommendation for clinical practice.