COVERED USES:

FDA Approved Indications:

• Rozerem indicated for the treatment of insomnia characterized by difficulty with sleep onset.
• Lunesta indicated for the treatment of insomnia.

Requests for a non-FDA approved (off-label) indication requires the proposed indication be listed in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex and is considered subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

NA

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

All of the following criteria must be met:

1. Adequate trial or contraindication to the intermittent use of zolpidem to assist with sleep plan
2. Documentation of a screen for treatable causes of insomnia:
   • Alcohol dependent sleep disorder
   • Anxiety disorder
   • Inadequate sleep hygiene
   • Menstrual cycle associated sleep disorder
   • Mood disorder
   • Obstructive sleep apnea
   • Sleep related gastroesophageal reflux disease
   • Uncontrolled pain
3. Documentation of a non-pharmacological sleep hygiene and cognitive behavioral plan.
   • Sleep only as much as you need to feel rested
   • Avoid forcing sleep
   • Avoid caffeinated beverages after lunch
   • Avoid smoking, especially in the evening
   • Avoid alcohol near bedtime: no "night cap"
   • Adjust bedtime environment
   • Keep a regular sleep schedule
   • Exercise regularly for at least 20 minutes
   • Do not go to bed hungry
   • Deal with your worries before bedtime

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization and reauthorization will be approved for up to one year.