Table 7. Level of evidence and recommendations for pharmacological treatment of insomnia.
| Sleep-onset insomnia | Maintenance insomnia and early waking | |||||||
|---|---|---|---|---|---|---|---|---|
| Category | Intervention | Level of evidence | Recommendation | Consensus rate | Voting rounds | Recommendation | Consensus rate | Voting rounds |
| BZD agonists | Zolpidem - Oral | 1 | Recommended | 100.00% | 1 | No consensus | 2 | |
| Zolpidem - Sublingual | 1 | Recommended | 94.12% | 1 | NOT Recommended | 87.50% | 2 | |
| Zolpidem - CR | 1 | No consensus | 2 | Recommended | 100.00% | 1 | ||
| Zolpidem – orodispersible | 1 | Recommended | 100.00% | 1 | NOT Recommended | 87.50% | 2 | |
| Zopiclone | 3 | Recommended | 94.12% | 1 | Recommended | 82.35% | 1 | |
| Eszopiclone | 1 | Recommended | 94.12% | 1 | Recommended | 100.00% | 1 | |
| BZD a | 5 | NOT Recommended | 82.35% | 1 | NOT Recommended | 75.00% | 2 | |
| DORAs | Suvorexant | 1 | Recommended | 82.35% | 1 | Recommended | 100.00% | 1 |
| Lemborexant | 2 | Recommended | 82.35% | 1 | Recommended | 100.00% | 1 | |
| Daridorexant | 1 | Recommended | 82.35% | 1 | Recommended | 94.12% | 1 | |
| Antidepressants | Trazodone | 2 | No consensus | 2 | Recommended | 82.35% | 1 | |
| Doxepin | 2 | No consensus | 2 | Recommended | 88.24% | 1 | ||
| Mirtazapine | 5 | No consensus | 2 | No consensus | 2 | |||
| Amitriptyline | 5 | No consensus | 2 | No consensus | 2 | |||
| Agomelatine | 5 | NOT Recommended | 82.35% | 1 | NOT Recommended | 75.00% | 2 | |
| Melatonin | Melatonin | 2 | NOT Recommended | 76.47% | 1 | NOT Recommended | 88.24% | 1 |
| Melatoninergic agonist | Ramelteon | 1 | Recommended | 88.24% | 1 | NOT Recommended | 76.47% | 1 |
| Antipsychotics | Quetiapine | 5 | NOT Recommended | 93.75% | 2 | NOT Recommended | 81.25% | 2 |
| Olanzapine | 5 | NOT Recommended | 82.35% | 1 | NOT Recommended | 76.47% | 1 | |
| Clozapine | 5 | NOT Recommended | 94.12% | 1 | NOT Recommended | 94.12% | 1 | |
| Periciazine | 5 | NOT Recommended | 100.00% | 1 | NOT Recommended | 100.00% | 1 | |
| Levomepromazine | 5 | NOT Recommended | 100.00% | 1 | NOT Recommended | 100.00% | 1 | |
| Chlorpromazine | 5 | NOT Recommended | 100.00% | 1 | NOT Recommended | 94.12% | 1 | |
| Anticonvulsants | Gabapentin | 5 | NOT Recommended | 88.24% | 1 | NOT Recommended | 82.35% | 1 |
| Pregabalin | 5 | NOT Recommended | 88.24% | 1 | NOT Recommended | 82.35% | 1 | |
| Others | Tienopramine | 3 | NOT Recommended | 94.12% | 1 | NOT Recommended | 94.12% | 1 |
| Promethazine | 5 | NOT Recommended | 100.00% | 1 | NOT Recommended | 100.00% | 1 | |
| Hydroxyzine | 5 | NOT Recommended | 100.00% | 1 | NOT Recommended | 100.00% | 1 | |
| Dimenhydrinate | 5 | NOT Recommended | 94.12% | 1 | NOT Recommended | 100.00% | 1 | |
| GABA | 3 | NOT Recommended | 94.12% | 1 | NOT Recommended | 94.12% | 1 | |
| Tryptophane | 5 | NOT Recommended | 100.00% | 1 | NOT Recommended | 94.12% | 1 | |
| Phytotherapeutics | Valeriana officinalis | 2 | NOT Recommended | 82.35% | 1 | NOT Recommended | 88.24% | 1 |
| Passiflora incarnata | 2 | NOT Recommended | 94.12% | 1 | NOT Recommended | 94.12% | 1 | |
| Matricaria recutita a | N/A | NOT Recommended | 77.78% | 2 | NOT Recommended | 76.47% | 1 | |
| Withania somnifera a | N/A | NOT Recommended | 77.78% | 2 | NOT Recommended | 76.47% | 1 | |
| Erythrina Mulungu | 5 | NOT Recommended | 76.47% | 1 | NOT Recommended | 82.35% | 1 | |
| Cannabinoids | Cannabis sativa | 3 | NOT Recommended | 94.12% | 1 | NOT Recommended | 100.00% | 1 |
| Cannabidiol | 3 | NOT Recommended | 100.00% | 1 | NOT Recommended | 94.12% | 1 | |
| Delta-9-THC | 3 | NOT Recommended | 100.00% | 1 | NOT Recommended | 100.00% | 1 | |
Abbreviations: BZD, Benzodiazepines; CR, Controlled release; DORAs, Dual orexin receptor antagonists; GABA, Gamma-aminobutyric acid, N/A, Not applicable; THC, Tetrahydrocannabinol.
a
Recommendations voted in group for the whole class, instead of individually for each intervention. All BZDs were assessed with level of evidence 5, except for flurazepam, assessed with level of evidence 4.