Pharmacy Prior Authorization Criteria

Sodium Oxybate Containing Agents - PA, NF

Indications for Prior Authorization

Xyrem (sodium oxybate) oral solution

• For diagnosis of Narcolepsy with Cataplexy (i.e., Narcolepsy Type 1)
  Indicated for the treatment of cataplexy in patients 7 years of age and older with narcolepsy.

• For diagnosis of Narcolepsy without Cataplexy (i.e., Narcolepsy Type 2)
  Indicated for the treatment of excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

Lumryz (sodium oxybate) extended-release oral solution

• For diagnosis of Narcolepsy with Cataplexy (i.e., Narcolepsy Type 1)
  Indicated for the treatment of cataplexy in patients 7 years of age and older with narcolepsy.

• For diagnosis of Narcolepsy without Cataplexy (i.e., Narcolepsy Type 2)
  Indicated for the treatment of excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution

• For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1)
  Indicated for the treatment of cataplexy in patients 7 years of age and older with narcolepsy.

• For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2)
  Indicated for the treatment of excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

• For diagnosis of Idiopathic Hypersomnia (IH)
  Indicated for the treatment of idiopathic hypersomnia (IH) in adults.

Criteria

Brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)*, Lumryz

*If member meets criteria above, please approve at NDC level.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1) [2, 3, A, C, D]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are present
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Patient is 7 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)*, Lumryz

*If member meets criteria above, please approve at NDC level.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1)

• Patient demonstrates a reduction in the frequency of cataplexy attacks associated with therapy
OR
• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy

Brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)*, Lumryz

*If member meets criteria above, please approve at NDC level.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2) [2, 3, B, C, E]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are absent
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Patient is 7 years of age or older
AND
• BOTH of the following:
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to both of the following:
• Generic modafinil or armodafinil
• Sunosi
AND
• ONE of the following
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant
OR
• Patient is not a candidate
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)*, Lumryz

*If member meets criteria above, please approve at NDC level.

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2)

• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy
AND
• BOTH of the following:
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to both of the following:
• Generic modafinil or armodafinil
• Sunosi
AND
• ONE of the following
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant
OR
• Patient is not a candidate

Xyrem, Brand Sodium Oxybate (Amneal manufacturer only, NDC 69238-2391-01)

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1) [2, 3, A, C, D]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are present
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Patient is 7 years of age or older
AND
• Trial and failure, or intolerance to brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Xyrem, Brand Sodium Oxybate (Amneal manufacturer only, NDC 69238-2391-01)

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1)

• One of the following:
• Patient demonstrates a reduction in the frequency of cataplexy attacks associated with therapy
OR
• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy
AND
• Trial and failure, or intolerance to brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)

Xyrem, Brand Sodium Oxybate (Amneal manufacturer only, NDC 69238-2391-01)

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2) [2, 3, B, C, E]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are absent
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Patient is 7 years of age or older
AND
• BOTH of the following:
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to both of the following:
• Generic modafinil or armodafinil
• Sunosi
AND
• ONE of the following
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant
OR
• Patient is not a candidate
AND
• Trial and failure, or intolerance to brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Xyrem, Brand Sodium Oxybate (Amneal manufacturer only, NDC 69238-2391-01)

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2)

• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy
AND
• Both of the following:
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to both of the following:
• Generic modafinil or armodafinil
• Sunosi
AND
• ONE of the following
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant
OR
• Patient is not a candidate
AND
• Trial and failure, or intolerance to brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)

Xyrem, brand Sodium Oxybate (Amneal manufacturer only, NDC 69238-2391-01)

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1) [2, 3, A, C, D]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are present
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Patient is 7 years of age or older
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Xyrem, Brand Sodium Oxybate (Amneal manufacturer only, NDC 69238-2391-01)

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2) [2, 3, B, C, E]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are absent
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Patient is 7 years of age or older
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming both of the following:
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to both of the following:
• Generic modafinil or armodafinil
• Sunosi
AND
• ONE of the following
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant
OR
• Patient is not a candidate
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Lumryz

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1) [2, 3, 12, A, C, D]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are present
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Patient is 7 years of age or older
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to TWO of the following:
• Brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)
• Xywav
• Wakix
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Lumryz

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2) [2, 3, 12, B, C, E]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible)
AND
• Symptoms of cataplexy are absent
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present
AND
• Patient is 7 years of age or older
AND
• BOTH of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to THREE of the following:
• Generic modafinil or armodafinil
• Sunosi
• Wakix
• Brand Sodium Oxybate (Hikma manufacturer only, NDC 00054-9628-57)
• Xywav
AND
• ONE of the following
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant
OR
• Submission of medical records (e.g., chart notes) confirming patient is not a candidate
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Xywav

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1) [F]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible) [14-18]
AND
• Symptoms of cataplexy are present [18]
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present [18]
AND
• Patient is 7 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Xywav

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy with Cataplexy (Narcolepsy Type 1)

• Patient demonstrates a reduction in the frequency of cataplexy attacks associated with therapy
OR
• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy

Xywav

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2) [G]

• Diagnosis of narcolepsy as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible) [14-18]
AND
• Symptoms of cataplexy are absent [18]
AND
• Symptoms of excessive daytime sleepiness (e.g., irrepressible need to sleep or daytime lapses into sleep) are present [18]
AND
• Patient is 7 years of age or older
AND
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to both of the following : [14-18]
• generic modafinil or generic armodafinil
• Sunosi
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant [14-18]
OR
• Patient is not a candidate
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Xywav

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Narcolepsy without Cataplexy (Narcolepsy Type 2)

• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy
AND
• Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to both of the following :
• generic modafinil or generic armodafinil
• Sunosi
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to an amphetamine (e.g., amphetamine, dextroamphetamine) or methylphenidate based stimulant
OR
• Patient is not a candidate

Xywav

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Idiopathic Hypersomnia (IH) [H]

• Diagnosis of idiopathic hypersomnia as confirmed by sleep study (unless the prescriber provides justification confirming that a sleep study would not be feasible) [14-18]
AND
• Symptoms of excessive daytime sleepiness (e.g., nap duration of longer than 60 minutes) are present [18]
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Psychiatrist
• Sleep Medicine Specialist

Xywav

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Idiopathic Hypersomnia (IH)

• Patient demonstrates a reduction in symptoms of excessive daytime sleepiness associated with therapy

P & T Revisions

2024-10-30, 2024-09-06, 2023-11-07, 2023-10-31, 2023-09-06, 2023-01-20, 2022-10-10, 2021-10-22, 2020-12-03, 2020-02-27, 2020-01-16, 2019-10-29

References

1. Xyrem Prescribing Information. Jazz Pharmaceuticals, Inc. Palo Alto, CA. December 2020.
2. Morgenthaler TI, Kapur VK, Brown T, et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin: An American Academy of Sleep Medicine report. Sleep. 2007 Dec;30(12):1705-11.
3. Wise MS, Arand DL, Auger RR, et al. Treatment of narcolepsy and other hypersomnias of central origin: An American Academy of Sleep Medicine review. Sleep. 2007 Dec;30(12):1712-27.
4. International classification of sleep disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
5. Sateia MJ. International classification of sleep disorders - third edition: highlights and modifications. CHEST. 2014 Nov;146(5):1387-1394.
6. Scammell TE. Clinical features and diagnosis of narcolepsy. UpToDate Website. April 2021. www.uptodate.com. Accessed October 21, 2021.
7. Per clinical consult with neurologist/sleep specialist, October 9, 2012 (confirmed on March 20, 2015).
8. Sun, Eric. Narcolepsy. 2021 Feb. Available at https://www.sleepfoundation.org/narcolepsy. Accessed October 21, 2021.
9. Franceschini, C., Pizza, F., et al. A practical guide to the pharmacological and behavioral therapy of Narcolepsy. Neurotherapeutics volume 18, pages 6–19 (2021). Available at https://link.springer.com/article/10.1007/s13311-021-01051-4. Accessed October 21, 2021.
10. Maski, K., Trotti, L., et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021;17(9):1895–1945. Available at https://jcsm.aasm.org/doi/10.5664/jcsm.9326. Accessed October 21, 2021.
11. Sodium Oxybate Prescribing Information. Hikma Pharmaceuticals, USA Inc. Berkeley Heights, NJ. October 2022.
12. Lumryz Prescribing Information. Avadel CNS Pharmaceuticals, LLC. Chesterfield, MO. October 2024.
13. Sodium Oxybate Prescribing Information. Amneal Pharmaceuticals, Inc. Bridgewater, NJ. April 2023.
14. International classification of sleep disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
15. Sateia MJ. International classification of sleep disorders - third edition: highlights and modifications. CHEST. 2014 Nov;146(5):1387-1394.
16. Scammell TE. Clinical features and diagnosis of narcolepsy. UpToDate Website. August 2020. www.uptodate.com. Accessed October 12, 2020.
17. Chevin, Ronald D. Idiopathic Hypersomnia. UpToDate Website. August 2021. www.uptodate.com. Accessed September 6, 2021.
18. Khan, Zeeshan, Trotti, Lynn Marie. Central Disorders of Hypersomnolence, Focus on the Narcolepsies and Idiopathic Hypersomnia. CHEST 2015 Jul; 148(1):262-273.
19. Xywav Prescribing Information. Jazz Pharmaceuticals, Inc. Palo Alto, CA. August 2022.

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End Notes

1. International classification of Sleep Disorders (ICSD-3) diagnostic criteria for narcolepsy with cataplexy (narcolepsy type 1) include: 1. Daily periods of irrepressible need for sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) for at least 3 months. 2. One or both of the following: cataplexy and a mean sleep latency of less than or equal to 8 minutes and 2 or more sleep onset REM periods (SOREMPs) on a multiple sleep latency test (MSLT) performed using standard techniques (a SOREMP within 15 minutes of sleep onset on the preceding nocturnal polysomnogram may replace 1 of the SOREMPs on the MSLT); or cerebrospinal fluid (CSF) hypocretin-1 concentration is low (less than 110 pg/mL or one-third of the normative values with the same standardized assay). 3. Exclusion of alternative causes of chronic daytime sleepiness by history, physical exam, and polysomnography. Other conditions that cause chronic daytime sleepiness include insufficient sleep, untreated sleep apnea, periodic limb movements of sleep, and idiopathic hypersomnia (chronic sleepiness but without SOREMPs or other evidence of abnormal REM sleep). In addition, the effects of sedating medications should be excluded. [4-6]
2. International classification of Sleep Disorders (ICSD-3) diagnostic criteria for narcolepsy without cataplexy (narcolepsy type 2) include: 1. Daily periods of irrepressible need for sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) for at least 3 months. 2. Cataplexy is absent 3. CSF hypocretin-1 levels, if measured, must not meet the narcolepsy type 1 criterion. 4. A mean sleep latency of less than or equal to 8 minutes and 2 or more sleep onset REM periods (SOREMPs) on a multiple sleep latency test (MSLT) performed using standard techniques (a SOREMP within 15 minutes of sleep onset on the preceding nocturnal polysomnogram may replace 1 of the SOREMPs on the MSLT). 5. Exclusion of alternative causes of chronic daytime sleepiness by history, physical exam, and polysomnography. Other conditions that cause chronic daytime sleepiness include insufficient sleep, untreated sleep apnea, periodic limb movements of sleep, and idiopathic hypersomnia (chronic sleepiness but without SOREMPs or other evidence of abnormal REM sleep). In addition, the effects of sedating medications should be excluded. [4-6]
3. Narcolepsy is often misdiagnosed. Treatment can often be given for the wrong reason if the patient has another condition with symptoms of excessive sleepiness. The diagnosis is the most important, and should be the focus in determining appropriate treatment. Both clinical symptoms and sleep study criteria (both daytime and nighttime tests) are needed to guide the diagnosis. [7]
4. Xyrem is very effective and can be considered a first-line treatment for cataplexy in patients with narcolepsy (narcolepsy type 1). Antidepressants have mixed issues. Currently, there are no safety data with antidepressants for the treatment of cataplexy, and tricyclics and SSRIs cause a lot of side effects including anticholinergic effects, sedation, impotence and EKG changes. Xyrem offers the advantage of treating cataplexy, and giving the patient more energy without the side effects compared to antidepressants. [7]
5. Generally, modafinil or armodafinil is given first for excessive daytime sleepiness without cataplexy (narcolepsy type 2), followed by on-demand stimulants, then by Xyrem. There are no head-to-head trials with Xyrem, but anecdotal and clinical practice reports find that patients receive a similar response as with modafinil/armodafinil, but not as good as stimulants for excessive daytime sleepiness. [7]
6. International classification of Sleep Disorders (ICSD-3) diagnostic criteria for narcolepsy with cataplexy (narcolepsy type 1) : 1. Daily periods of irrepressible need for sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) for at least 3 months. 2. Presence of one or both of the following: cataplexy and a mean sleep latency of less than or equal to 8 minutes and 2 or more sleep onset REM periods (SOREMPs) on a multiple sleep latency test (MSLT) performed using standard techniques (a SOREMP within 15 minutes of sleep onset on the preceding nocturnal polysomnogram may replace 1 of the SOREMPs on the MSLT); or cerebrospinal fluid (CSF) hypocretin-1 concentration is less than or equal to 110 pg/mL or less than one-third of the mean values obtained in normal subjects with the same standardized assay). 3. Exclusion of alternative causes of chronic daytime sleepiness by history, physical exam, and polysomnography. Other conditions that cause chronic daytime sleepiness include insufficient sleep, untreated sleep apnea, periodic limb movements of sleep, and idiopathic hypersomnia (chronic sleepiness but without SOREMPs or other evidence of abnormal REM sleep). In addition, the effects of sedating medications should be excluded. [14-18]
7. International classification of Sleep Disorders (ICSD-3) diagnostic criteria for narcolepsy without cataplexy (narcolepsy type 2) : 1. Daily periods of irrepressible need for sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) for at least 3 months. 2. Cataplexy is absent 3. CSF hypocretin-1 levels, if measured, is greater than 110 pg/mL or greater than one-third of the mean values obtained in normal subjects with the same standardized assay) 4. A mean sleep latency of less than or equal to 8 minutes and 2 or more sleep onset REM periods (SOREMPs) on a multiple sleep latency test (MSLT) performed using standard techniques (a SOREMP within 15 minutes of sleep onset on the preceding nocturnal polysomnogram may replace 1 of the SOREMPs on the MSLT). 5. Exclusion of alternative causes of chronic daytime sleepiness by history, physical exam, and polysomnography. Other conditions that cause chronic daytime sleepiness include insufficient sleep, untreated sleep apnea, periodic limb movements of sleep, and idiopathic hypersomnia (chronic sleepiness but without SOREMPs or other evidence of abnormal REM sleep). In addition, the effects of sedating medications should be excluded. [14-18]
8. International classification of Sleep Disorders (ICSD-3) diagnostic criteria for idiopathic hypersomnia requires all of the following: 1. Daily periods of irrepressible need for sleep or daytime lapses into sleep (i.e., excessive daytime sleepiness) for at least 3 months 2. Cataplexy is absent 3. A multiple sleep latency test (MSLT) documents fewer than two sleep-onset rapid eye movement periods (SOREMPs), or no SOREMPs if the REM sleep latency on the preceding polysomnogram was ≤15 minutes 4. The presence of at least one of the following: MSLT shows a mean sleep latency of ≤8 minutes or Total 24-hour sleep time is ≥660 minutes (typically 12 to 14 hours) on 24-hour polysomnography or by wrist actigraphy in association with a sleep log 5. Insufficient sleep syndrome is ruled out (if deemed necessary, by lack of improvement of sleepiness after an adequate trial of increased nocturnal time in bed, preferably confirmed by at least a week of wrist actigraphy) 6. No better explanation by another sleep disorder, medical or psychiatric disorder or use of drugs or medications. [14-18]

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Revision History

• 2024-10-30: 2024 Annual Review
• 2024-09-06: 2024 Annual Review
• 2023-11-07: Program update to remove Xyrem as preferred option. Xyrem will now require trial of preferred Sodium Oxybate Authorized Brand Alternative (mfg HIKMA).
• 2023-10-31: update guideline
• 2023-09-06: Added Xyrem ABA (manufactured by Amneal) as target to guideline.
• 2023-01-20: update guideline
• 2022-10-10: 2022 Annual Review.
• 2021-10-22: 2021 Annual Review.
• 2020-12-03: 2020 Annual Review: updated reauthorization criteria for both indications; Updating trial and failure language for the embedded step through modafinil/armodafinil and Sunosi to read: "Trial and failure, contraindication (e.g., safety concerns, not indicated for patient's age/weight) or intolerance to"
• 2020-02-27: updated criteria
• 2020-01-16: updated criteria
• 2019-10-29: Annual Review- no changes

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