Ramelteon for insomnia symptoms in a community sample of adults with generalized anxiety disorder: an open label study

J Clin Sleep Med. 2009 Feb 15;5(1):28-33.


Objective: Prior research confirms the relationship between insomnia and psychiatric disorders, particularly anxiety and depression. The effectiveness and tolerability of ramelteon was examined in adult generalized anxiety disorder (GAD) patients with insomnia symptoms.

Methods: Twenty-seven adults with sleep disturbance meeting DSM-IV diagnostic criteria for GAD and partially responsive on an SSRI or SNRI by randomization visit (as signified by a Hamilton Anxiety scale [HAMA] maximum score of 15 and minimum of 8, Clinical Global Impressions Severity of Illness [CGI-S] scale of < or = 4 and > or = 2 [measuring anxiety symptoms], CGI-S of 4 [measuring insomnia symptoms], > or = 5 on the Pittsburgh Sleep Quality Index [PSQI], and > or = 10 on the Epworth Sleepiness Scale [ESS]) were treated openly for 10 weeks on ramelteon 8 mg at bedtime. Analysis was conducted using repeated measures methodology. Patient reported sleep diaries were maintained throughout the study.

Results: Significant symptom reduction was observed on all scales (HAMA, ESS, CGI-I, CGI-S), with subjects falling asleep faster and sleeping longer. Headache upon stopping ramelteon, daytime tiredness, agitation, and depression were the most commonly reported side effects and were cited as transient.

Conclusion: Data from this 12-week open-label study suggests ramelteon is an effective and generally well tolerated treatment for insomnia symptoms in this community sample of adults with GAD.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anxiety Disorders / drug therapy*
  • Anxiety Disorders / psychology
  • Depressive Disorder / drug therapy
  • Depressive Disorder / psychology
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hypnotics and Sedatives / administration & dosage*
  • Hypnotics and Sedatives / adverse effects
  • Indenes / administration & dosage*
  • Indenes / adverse effects
  • Male
  • Middle Aged
  • Personality Inventory
  • Receptor, Melatonin, MT1 / drug effects
  • Receptor, Melatonin, MT2 / drug effects
  • Sleep Initiation and Maintenance Disorders / drug therapy*
  • Sleep Initiation and Maintenance Disorders / psychology
  • Surveys and Questionnaires


  • Hypnotics and Sedatives
  • Indenes
  • Receptor, Melatonin, MT1
  • Receptor, Melatonin, MT2
  • ramelteon