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Psychiatric Pharmacy Practice Resident, Western Missouri Mental Health Center, Kansas City, MO
Clinical Pharmacist, Psychiatric Pharmacy Residency Coordinator, Western Missouri Mental Health Center; Adjunct Faculty for University of Missouri–Kansas City and University of Kansas Schools of Pharmacy, Kansas City
Assistant Professor, School of Pharmacy, University of Missouri–Kansas City
Reprints: Dr. Nelson, School of Pharmacy, Division of Pharmacy Practice, University of Missouri–Kansas City, 2464 Charlotte St., Kansas City, MO 64108, fax 816/512-7478, nelsonla{at}umkc.edu
OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of ramelteon in the treatment of primary insomnia in adults, including elderly adults.
DATA SOURCES: MEDLINE (1966–July 2008) and PsycINFO (1985–July 2008) literature searches were conducted to identify clinical data involving ramelteon. The manufacturer provided a summary of clinical data and abstracts of unpublished studies.
STUDY SELECTION AND DATA EXTRACTION: All primary literature, including abstracts, focusing on the pharmacology and pharmacokinetics of ramelteon and clinical trials evaluating its use was reviewed. Information deemed most relevant was incorporated. Our search revealed 5 controlled trials evaluating the short-term efficacy and safety of ramelteon in the treatment of primary insomnia: 3 in adults and 2 in geriatric patients. Additionally, 2 studies in abstract form that evaluated the long-term effects of ramelteon were included.
DATA SYNTHESIS: Ramelteon is the first selective melatonin receptor
agonist approved by the Food and Drug Administration. It has no affinity for
the 
-aminobutyric acid receptor complex or for receptors that bind
acetylcholine, cytokines, dopamine, norepinephrine, neuropeptides, opiates,
and serotonin. In the only published Phase 3 trial in adults, investigators
found that latency to persistent sleep decreased with ramelteon to 31.5
± 2.91 minutes with 8 mg and 29.5 ± 2.96 minutes with 16 mg
compared with 42.5 ± 2.97 minutes with placebo (p = 0.007 and p =
0.002, respectively). Total sleep time was not significantly different from
that with placebo. Safety data from short-term studies showed advantages of
ramelteon over other sleep agents including no potential for abuse, no rebound
insomnia, and lack of effect on motor and cognitive function. The adverse
effects seen most frequently in ramelteon clinical trials were headache,
somnolence, fatigue, nausea, dizziness, and insomnia. The overall incidence
was similar to that of placebo.
CONCLUSIONS: Ramelteon offers a novel mechanism of action for the treatment of insomnia. Studies support its short- and long-term use in adults and elderly adults for the treatment of primary insomnia characterized by difficulty with sleep initiation. Efficacy studies comparing ramelteon with other sleep agents are needed to further solidify the role of ramelteon in the treatment of insomnia.
Key Words: insomnia, ramelteon, sedative–hypnotics
Published Online, July 23, 2008. www.theannals.com, DOI 10.1345/aph.1K676
THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-08-017-H01-P
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