Can ramelteon (rozerem) cause next day drowsiness?

Ramelteon and Next-Day Drowsiness

Ramelteon generally does not cause significant next-day drowsiness, with only isolated and inconsistent evidence of mild next-day effects that typically resolve with continued use. 1

Evidence on Next-Day Effects

• Three clinical studies specifically assessed next-day impairment associated with ramelteon, with the majority showing no significant residual effects compared to placebo 1
• In a 35-night study, ramelteon 8 mg showed only small, isolated differences from placebo in next-day effects:
  • At Week 1: Slightly increased fatigue (46 mm vs 42 mm on a 100 mm scale) 2
  • At Week 3: Slightly lower immediate recall (7.5 vs 8.2 words out of 16) and more sluggishness (27 mm vs 22 mm on a 100 mm scale) 2
  • By Week 5: No differences in next-morning residual effects compared to placebo 2
• Roth and colleagues found no significant residual effects on digit-symbol substitution test (DSST), immediate and delayed recall, subjective alertness, or concentration in older adults 1
• Zammitt et al. reported only isolated, transient impairments in immediate recall (week 3 only), delayed recall (week 1 only), alertness (week 5), and concentration (week 1) 1
• Mayer found no consistent evidence of next-day impairment in alertness, recall, DSST, or visual analog scales of mood, energy, or cognition 1

Safety Profile Compared to Other Hypnotics

• Unlike benzodiazepines and non-benzodiazepine hypnotics, ramelteon has not been associated with significant next-day cognitive or motor impairment 3, 4
• The most common adverse events reported with ramelteon include headache (7%), dizziness (5%), somnolence (5%), and fatigue (4%), which are generally mild to moderate in nature 5, 6
• Ramelteon has no abuse potential and is not classified as a controlled substance, making it a suitable option for patients with a history of substance use disorders 3, 4

Clinical Considerations

• Ramelteon is primarily indicated for sleep onset insomnia rather than sleep maintenance problems 3, 6
• The American Academy of Sleep Medicine suggests ramelteon as a treatment option for sleep onset insomnia with a weak recommendation, noting its relatively benign side effect profile 1
• The efficacy of ramelteon for reducing sleep latency is modest (mean decrease of 9.57 minutes) compared to placebo 1
• In elderly patients, ramelteon may be preferable to other hypnotics due to its minimal next-day effects and low risk of falls or cognitive impairment 7, 8

Practical Recommendations

• Administer ramelteon 8 mg approximately 30 minutes before bedtime 2
• Avoid alcohol when using ramelteon due to potential additive sedative effects 3
• Monitor for potential side effects during the first few weeks of treatment, as any mild next-day effects typically resolve by week 5 of continued use 2
• Ramelteon can be safely used in patients with mild to moderate obstructive sleep apnea without worsening their condition 9