Ramelteon The ABCs of the Sleep Aid

ramelteon

The Bottom Line

Ramelteon is a drug that is prescribed to help people fall asleep faster. It typically causes only mild side effects.

ramelteon

The Full Story

Insomnia is a common medical issue, affecting up to 40% of the adult population. The treatment of insomnia can include both non-pharmacologic methods (such as relaxation therapy and attention to sleep hygiene) as well as medications. Many of the medications traditionally used for the treatment of insomnia are associated with undesirable side effects.

The prescription drug ramelteon (Rozerem) is a sleep aid prescribed to help reduce the time it takes to fall asleep. Unlike most drugs used for sleep, ramelteon works by stimulating the same receptors in the body as our own melatonin. Melatonin controls our sleep-wake cycle. While we don’t know exactly how it all works, we do know that when the sun goes down our bodies release melatonin naturally to cause drowsiness. Ramelteon is prescribed specifically to help people fall asleep – but not stay asleep.

The typical ramelteon dosage is 8 mg taken 30 minutes before bedtime. Do not take ramelteon with or immediately after a high-fat meal because the maximum concentration of the drug is lowered. Additionally, food can delay absorption by nearly an hour.

Unlike other drugs used for sleep, so far there is no evidence that ramelteon causes dependence (people do not become addicted) even after prolonged use. It is also uncommon for people to exhibit symptoms of withdrawal after they stop using ramelteon.

Overall, ramelteon is well tolerated by most individuals who take it. Unlike many of the other medications used for the treatment of insomnia, ramelteon does not cause significant adverse effects on memory, motor function, or cognition. The side effects of ramelteon are mild and include drowsiness, dizziness, nausea, and headache. Some people have reported performing activities with no memory of the event, such as driving or eating; this same effect occurs with other sleep aids. Nightmares have been reported to occur after use of melatonin and may also rarely occur after therapeutic use of ramelteon.

Animal studies with very large doses have shown some negative effects on the fetus. Human studies are lacking but, because of the animal effects, ramelteon is not approved for use during pregnancy.

If you think someone might have unintentionally taken too much ramelteon (or any drug), immediately call Poison Control at 1-800-222-1222 or check the webPOISONCONTROL® online tool for help. Whether you call or log on, expert assistance is available 24 hours a day.

Pela Soto, PharmD, BSHS, BS
Certified Specialist in Poison Information

Poisoned?

Call 1-800-222-1222 or

HELP ME online

Prevention Tips

  • Ramelteon is used for sleep. As expected, it can cause drowsiness. Do not drive or use dangerous machinery until you know how ramelteon affects you.
  • Most drugs used for sleep can interact with alcohol and other medications that cause drowsiness. Ask your doctor, pharmacist, or Poison Control to perform a drug interaction check before taking ramelteon.
  • Keep all drugs out of the reach and sight of children.

This Really Happened

A mother of a 2-year-old boy called Poison Control because the boy had gotten into her ramelteon tablets. He was able to open the child-resistant cap himself, but was not alone with the medication for long. Poison Control helped mom estimate how many tablets could be missing based on the date the prescription was filled and how many were left in the bottle. Even though ramelteon is not prescribed for children, Poison Control had enough data from case reports of children getting into the drug by mistake to conclude that the amount missing would be okay to watch at home with follow-up. Two hours later, Poison Control called mom back to check in. The boy was now doing well but had been a little drowsy earlier. The following day, Poison Control called again and the boy was acting like his normal self. 


For More Information

Sleep Disorder Problems [internet]. Arlington VA: National Sleep Foundation. [accessed Sept 20, 2016]. 

Prescription sleeping pills: What’s right for you? [internet]. Rochester MN: Mayo Clinic; 2014. [accessed Sept 20, 2016]. 


References

Karim A, Tolbert D, Cao C. Disposition kinetics and tolerance of escalating single doses of ramelteon, a high-affinity MT1 and MT2 melatonin receptor agonist indicated for treatment of insomnia. J Clin Pharmacol. 2006 Feb;46(2):140-8. 

Lee DC. Sedative-hypnotics. In: Hoffman R, Howland M, Lewin NA, Nelson LS, Goldfrank L, editors. Goldfrank’s toxicologic emergencies. 10th ed. New York: McGraw Hill; 2014. p. 1002-9.

Product Information. Rozerem. Takeda Pharmaceuticals. Revised 11/2010.

Pandi-Perumal SR, Srinivasan V, Spence DW, Moscovitch A, Hardeland R, Brown GM, Cardinali DP. Ramelteon: a review of its therapeutic potential in sleep disorders. Adv Ther. 2009 Jun;26(6):613-26. 

Shah C, Kablinger A. Ramelteon-induced nightmares: A case report. Asian J Psychiatr. 2015 Dec;18:111-2. 

Todd CM, Forrester MB: Ramelteon ingestions reported to Texas poison centers, 2005-2009. J Emerg Med 2012;43:e189-93.

Poisoned?

Call 1-800-222-1222 or

HELP ME online

Prevention Tips

  • Ramelteon is used for sleep. As expected, it can cause drowsiness. Do not drive or use dangerous machinery until you know how ramelteon affects you.
  • Most drugs used for sleep can interact with alcohol and other medications that cause drowsiness. Ask your doctor, pharmacist, or Poison Control to perform a drug interaction check before taking ramelteon.
  • Keep all drugs out of the reach and sight of children.

This Really Happened

A mother of a 2-year-old boy called Poison Control because the boy had gotten into her ramelteon tablets. He was able to open the child-resistant cap himself, but was not alone with the medication for long. Poison Control helped mom estimate how many tablets could be missing based on the date the prescription was filled and how many were left in the bottle. Even though ramelteon is not prescribed for children, Poison Control had enough data from case reports of children getting into the drug by mistake to conclude that the amount missing would be okay to watch at home with follow-up. Two hours later, Poison Control called mom back to check in. The boy was now doing well but had been a little drowsy earlier. The following day, Poison Control called again and the boy was acting like his normal self.