The Medical Letter on Drugs and Therapeutics
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1221
Ramelteon (Rozerem) for Insomnia
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Ramelteon (Rozerem – Takeda), a melatonin receptor agonist, has been approved by the FDA for treatment of insomnia characterized by difficulty falling asleep. Unlike all other prescription hypnotics, which are classified as schedule IV drugs, ramelteon is not a controlled substance.

DRUGS FOR INSOMNIA — Melatonin itself is available in the US only as a “dietary supplement”.1 Its effectiveness as a hypnotic remains to be established, and the potency and purity of the commercial preparations are suspect.

First-generation antihistamines such as diphenhydramine (Nytol, and others) are available as “sleepaids” without a prescription. Tolerance to their sedative effects may develop rapidly, and they can cause nextday sedation. Benzodiazepines and nonbenzodiazepine drugs that act on the benzodiazepine component of the GABA-A receptor are the most commonly used prescription ... more      

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Title: Ramelteon (Rozerem) for Insomnia
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